Gastroenterology Today - Summer 2019 by Media Publishing Company

Volume 29 No. 2

Summer 2019

Gastroenterology Today Improving Quality in Endoscopy Guess the three diagnoses in these Gastric Images to win an iPad

See page 3

What approach has 18 Week Support taken with regards to building an expert insourcing team? Matthew’s Perspective: Dr Matthew Banks is the Clinical Director for 18 Week Support Gastroenterology. He believes it starts with recruiting the best clinicians. ‘At 18 Week Support we set the bar very high. We only recruit clinicians whose JAG performance data is well above the national standards. In addition, we monitor each clinician’s KPIs while they work with 18 WS. While the JAG data is an excellent quality indicator, we now want to go a step beyond that and monitor the Non-Technical skills (NTS) of each clinician as well. We now know that NTS plays an important role in safe and effective team performance. Therefore, in our quest to develop excellent teams who deliver a world-class service, we must focus on NTS’. Tammy and Lisa’s Perspective: Tammy Kingstree is Lead Nurse for Endoscopy. ‘It is extremely important that there are good working relationships within the team. This starts with strong leadership from our senior nurse coordinators who are trained to manage the patient pathway, manage a team of staff they may not know and to deal effectively with any issues which may arise on the day’. Lisa Phillips is Lead Nurse for Endoscopy. ‘The team objectives are clear. Excellent patient experience and good patient outcomes. Because the objectives are clear, team cohesion and focus are exceptionally good. It therefore shouldn’t matter that we are in an unfamiliar endoscopy unit, the service should be seamless. If it isn’t, we do not stop until we get it right.

18 Week Support Gastroenterology: Building Expert Teams

If you have an excellent NHS record and want to help clear NHS waiting list backlogs, reduce RTT waiting times and provide high-quality patient care, get in touch by calling on 020 3892 6162 or email Gastro.Recruitment@18weeksupport.com

One 5-ASA stands out from the crowd; so your UC patients don’t have to.

Unique among 5-ASAs, only PENTASA has ethyl cellulose coated microgranules that release mesalazine independent of pH.1-10 Alongside this, PENTASA: • Is effective in 2 weeks11,12 and remission is maintained for 12 months13,14 • Is effective throughout the entire colon including left-sided disease1,13-15 • Offers a broad range of formulations allowing high dose*, once-daily dosing: 4 g – active, 2 g – remission1,16-21 Giving your mild to moderate UC patients the confidence to enjoy life. *1 g tablets, 1 g, 2 g and 4 g sachets Prescribing Information: Pentasa® all formulations. Please consult the full Summary of Product Characteristics before prescribing. Name of Product(s): Pentasa® Sachet prolonged release granules 1g, 2g and 4g; Pentasa® Slow Release Tablets 500mg and 1g; Pentasa® Mesalazine Enema 1g; Pentasa® Suppositories 1g. Composition: Sachets: contain 1g, 2g or 4g mesalazine. Tablets: contain 500mg or 1g mesalazine. Enema: contains 1g mesalazine in 100ml of aqueous suspension. Suppositories: contain 1g mesalazine. Indication: Sachets and Tablets: Mild to moderate ulcerative colitis. Enema: ulcerative colitis affecting the distal colon and rectum. Suppositories: ulcerative proctitis. Dosage: Sachets and Tablets: Adults: Active disease: up to 4g once daily or in 2–4 divided doses. Maintenance treatment: 2g once daily. Sachets and 500mg tablet: Children over 6 years old: Active disease: individual dosing, starting with 30-50 mg/kg/day in divided doses (total dose should not exceed 4g/day). Maintenance treatment: individual dosing, starting with 15-30 mg/kg/day in divided doses (total dose should not exceed 2g/day). Enema: Adults: one enema at bedtime. Suppositories: Adults: 1 suppository daily.Contraindications: patients with known hypersensitivity to salicylates or any of the excipients and patients with severe liver and/or renal impairment. Special Warnings and Precautions: Blood tests (differential blood count: liver function parameters such as ALT or AST; serum creatinine) and urinary status should be determined prior to and during treatment, at the discretion of the treating physician. Caution is recommended in patients with impaired hepatic function. PENTASA should not be used in patients with impaired renal function. Mesalazine- induced renal toxicity should be considered, if renal function deteriorates during treatment. Patients with pulmonary disease, in

particular asthma, should be very carefully monitored during a course of treatment with PENTASA. Patients with a history of adverse drug reactions to preparations containing sulphasalazine (risk of allergy to salicylates), should be kept under close medical surveillance on commencement of a course of treatment with PENTASA. Should PENTASA cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever, severe headache and rash, the treatment should be discontinued immediately. Mesalazine-induced cardiac hypersensitivity reactions (myo- and pericarditis) have been reported rarely. Treatment should be discontinued on suspicion or evidence of these reactions. In patients who are concomitantly treated with azathioprine, or 6-mercaptopurine, or thioguanine, a possible increase in the myelosuppressive effects of azathioprine, or 6-mercaptopurine, or thioguanine should be taken into account. There may be a decrease in the anticoagulant effect of warfarin. Do not use during pregnancy and lactation except when the potential benefits outweigh the possible risk. Sachets: Caution is recommended in patients with active peptic ulcer disease. The concurrent use of other known nephrotoxic agents, such as NSAID’s and azathioprine, may increase the risk of other renal reactions. Enema and Suppositories: If a patient develops dehydration while on treatment with mesalazine, normal electrolyte levels and fluid balance should be restored as soon as possible. Side effects: For the full list of side effects please consult the Summaries of Product Characteristics. PENTASA 1g 2g 4g sachets: Common: Headache, Diarrhoea, Abdominal pain, Nausea, Vomiting, Flatulence. Rare: Acute pancreatitis. Very rare: Benign intracranial hypertension, Pericardial effusion, Quincke’s oedema, Dermatitis allergic, Hypersensitivity reaction including anaphylactic reaction, Drug Reaction

with Eosinophilia and Systemic Symptoms (DRESS). Pentasa all formulations: Rare: Dizziness, Myocarditis, Pericarditis, Photosensitivity. Very rare: Altered blood counts, Hypersensitivity reaction such as Allergic exanthema, Drug fever, Lupus erythematosus syndrome, Pancolitis, Peripheral neuropathy, Allergic and Fibrotic lung reactions, Changes in liver function parameters, Hepatitis and Cholestatic hepatitis, (Reversible) Alopecia, Renal function impairment interstitial, nephritis (incl. acute and chronic) Renal insufficiency, reversible Oligospermia. PENTASA 1g 2g 4g sachets, 1g enema and 1g suppository: Common: Rash. Rare: Increased amylase. Very rare: Cirrhosis, Hepatic failure, Erythema multiforme Stevens Johnson Syndrome (SJS), Nephrotic syndrome, Urine discolouration. PENTASA 500mg and 1g tablets, 1g enema and 1g suppository: Rare: Abdominal pain, Diarrhoea, Flatulence, Nausea, Vomiting, Headache. Very Rare: Acute Pancreatitis. Nature and Contents of Container: Sachets: Cartons contain 50 x 1g sachets, 60 x 2g sachets or 30 x 4g sachets. Tablets: Cartons contain 100 x 500mg and 60 x 1g tablets in blister strips. Enema: Cartons contain 7 x 100ml enemas. Suppositories: Cartons contain 28 x 1g suppositories in blister strips.Marketing Authorisation Number: Sachet 1g: 03194/0075. Sachet 2g: 03194/0102. Sachet 4g: PL 03194/0117. Tablets 500mg: 03194/0044. Tablets 1g: 3194/0108. Enema: 03194/0027. Suppositories: 03194/0045. Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom. Legal Category: POM. Basic NHS Price: £30.74 for 50 x 1g sachets. £73.78 for 60 x 2g sachets. £73.78 for 30 x 4g sachets. £30.74 for 100 x 500mg Tablets. £36.89 for 60 x 1g Tablets. £17.73 for 7 x enemas. £40.01 for 28 x 1g suppositories. Date of Preparation of Prescribing Information: January 2019. Pentasa® is a registered trademark. PA/035/2019/UK.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/ yellowcard. Adverse events should also be reported to Ferring Pharmaceuticals Ltd. Tel: 0800 111 4126. Email: medical@ferring.com References: 1. Pentasa Slow Release Tablets 500 mg. SmPC. 2. Sulfasalazine 250 mg/5 ml Oral Suspension. SmPC. 3. Octasa 400 mg MR Tablets. SmPC. 4. Asacol 400 mg MR Tablets. SmPC. 5. Mezavant XL 1200 mg, Gastro-resistant, Prolonged Release Tablets. SmPC. 6. Salofalk 500 mg Gastro-resistant Prolonged Release Granules. SmPC. 7. Colazide 750 mg Capsules. SmPC. 8. Olsalazine Sodium 250 mg Capsules. SmPC. 9. Salazopyrin En-Tabs. SmPC. 10. Salazopyrin Tablets SmPC. 11. Probert C.S.J, et al. J Crohn’s Colitis. 2014;8:200–7. 12. Marteau P, et al. Gut. 2005;54(7):960–5. 13. Dignass AU, et al. Clin Gastroenterol Hepatol. 2009;7(7):762– 9. 14. Bokemeyer B, et al. J Crohn’s Colitis. 2012;6:476-82. 15. Flourie B, et al. Aliment Pharmacol Ther. 2013;37(8):767–75. 16. Pentasa Slow Release Tablets 1 g. SmPC. 17. Pentasa Sachet 1 g. SmPC. 18. Pentasa Sachet 2 g. SmPC. 19. Pentasa Sachet 4 g. SmPC. 20. Pentasa Enema 1 g. SmPC. 21. Pentasa Suppositories 1 g. SmPC. Date of preparation: May 2019. Job code: PA/323/2019/UKa

MAKING A

Positive UC action. Positive UC outcomes.

Positive UC a DIFFERENCE

CONTENTS

What approach has 18 Week Support CONTENTS taken with regards to building an expert insourcing team? Matthew’s Perspective:

Gastroenterology Today

Dr Matthew Banks is the Clinical Director for 18 Week Support Gastroenterology. He believes it starts with recruiting the

best clinicians. ‘At 18 Week Support we set the bar very high. We only recruit clinicians whose JAG performance data is well above the national standards. In addition, we monitor each clinician’s KPIs while they work with 18 WS. While the JAG data is an excellent quality indicator, we now want to go a step beyond that and monitor the Non-Technical skills (NTS) of each

EDITORS COMMENT

clinician as well. We now know that NTS plays an important role in safe and effective team performance. Therefore, in our This issue edited by: quest to develop excellent teams who deliver a world-class service, we must focus on NTS’.

Dr Ben Shandro c/o Media Publishing Company Tammy Kingstree is Lead Nurse for Endoscopy. Media House ‘It is extremely important that there are good working relationships within the team. This starts with strong leadership from 48 High Street our senior nurse coordinators who are trained to manage the patient pathway, manage a team of staff they may not know SWANLEY, Kent BR8 8BQ and to deal effectively with any issues which may arise on the day’. Tammy and Lisa’s Perspective:

CASE REPORT Primary Aorto-enteric Fistula

FEATURE S howing the true value of probiotics

ADVERTISING & CIRCULATION: Media Publishing Company team cohesion and focus are exceptionally good. It therefore shouldn’t matter that we are in an unfamiliar endoscopy unit, Media House, 48 High Street the service should be seamless. If it isn’t, we do not stop until we get it right. SWANLEY, Kent, BR8 8BQ If you have an excellent NHS record and want to help clear NHS waiting listTel: backlogs, reduce RTT waiting times and provide 01322 660434 Fax: 01322 666539 high-quality patient care, get in touch by calling on 020 3892 6162 or email Gastro.Recruitment@18weeksupport.com E: info@mediapublishingcompany.com www.MediaPublishingCompany.com Lisa Phillips is Lead Nurse for Endoscopy.

NEWS

COMPANY NEWS

‘The team objectives are clear. Excellent patient experience and good patient outcomes. Because the objectives are clear,

COVER STORY What are the three diagnoses evident in these gastric images? Submit your answers to jawuku@18weeksupport.com to enter our prize draw to win an iPad! The Competition will end on the 21st of June. The winner will be announced on the 18 Week Support website. What approach has 18 Week Support taken with regards to building an expert insourcing team? Matthew’s Perspective: Dr Matthew Banks is the Clinical Director for 18 Week Support Gastroenterology. He believes it starts with recruiting the best clinicians. ‘At 18 Week Support we set the bar very high. We only recruit clinicians whose JAG performance data is well above the national standards. In addition, we monitor each clinician’s KPIs while they work with 18 WS. While the JAG data is an excellent quality indicator, we now want to go a step beyond that and monitor the Non-Technical skills (NTS) of each clinician as well. We now know that NTS plays an important role in safe and effective team performance. Therefore, in our quest to develop excellent teams who deliver a world-class service, we must focus on NTS’.

Lisa Phillips is Lead Nurse for Endoscopy. ‘The team objectives are clear. Excellent patient experience and good patient outcomes. Because the objectives are clear, team cohesion and focus are exceptionally good. It therefore shouldn’t matter that we are in an unfamiliar endoscopy unit, the service should be seamless. If it isn’t, we do not stop until we get it right.

COPYRIGHT: Media Publishing Company Media House 48 High Street SWANLEY, Kent, BR8 8BQ PUBLISHERS STATEMENT: The views and opinions expressed in this issue are not necessarily those of the Publisher, the Editors or Media Publishing Company. Next Issue Autumn 2019 Subscription Information – Summer 2019 Gastroenterology Today is a tri-annual publication currently sent free of charge to all senior qualified Gastroenterologists in the United Kingdom. It is also available by subscription to other interested individuals and institutions. UK: Other medical staff - £18.00 inc. postage Non-medical Individuals - £24.00 inc. postage Institutions Libraries Commercial Organisations - £48.00 inc. postage Rest of the World: Individuals - £48.00 inc. postage Institutions Libraries Commercial Organisations - £72.00 inc. postage We are also able to process your subscriptions via most major credit cards. Please ask for details. Cheques should be made payable to MEDIA PUBLISHING. Designed in the UK by me&you creative

For more information please contact: Ian Yuill, Director of Business Development & Recruitment on 0203 869 8792 or visit www.18weeksupport.com

GASTROENTEROLOGY TODAY - SUMMER 2019

Tammy and Lisa’s Perspective: Tammy Kingstree is Lead Nurse for Endoscopy. ‘It is extremely important that there are good working relationships within the team. This starts with strong leadership from our senior nurse coordinators who are trained to manage the patient pathway, manage a team of staff they may not know and to deal effectively with any issues which may arise on the day’.

PUBLISHING DATES: February, June and October.

Getting on with

their lives By getting on with

their steroid For autoimmune hepatitis

For induction of remission of mild to moderate active ileo-caecal Crohn’s disease For induction of remission of active collagenous colitis

The only budesonide with three indications

Budesonide, the Dr Falk way

Efficacy localised at the site of the diseases1-4 Limiting the risk of systemic side effects2-4 Prescribing Information (Please refer to full SPC before prescribing) Presentation: Budenofalk® gastro-resistant granules, each sachet contains 9mg budesonide, Budenofalk® gastro-resistant capsules, each containing 3mg budesonide. Indications: Induction of remission of mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Induction of remission of active collagenous colitis. Autoimmune hepatitis (capsules only). Dosage: Adults: For Crohn’s disease and collagenous colitis: one sachet or three capsules daily with liquid half an hour before food, without chewing or crushing, or one capsule three times daily. Limit treatment to 8 weeks, then withdraw gradually. For autoimmune hepatitis: one capsule three times daily. Possibly combine with azathioprine. Maintenance of remission: one capsule twice daily. Revert to 3 capsules daily if transaminases ALAT and/ or ASAT elevate again. Treat until remission is achieved or 24 months. Children: Not recommended; safety and efficacy not established. Contraindications: hypersensitivity to any constituent. Hepatic cirrhosis. Warnings/Precautions: Change from other steroids may result in symptoms due to reduced systemic steroids. Use with caution in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts or family history of glaucoma or diabetes or any condition in which glucocorticosteroids may have undesirable effects. Not appropriate for upper GI Crohn’s or extraintestinal symptoms. Long term, high dose use may result in glucocorticosteroid systemic effects. Infection: suppression of the inflammatory response and immune function increases susceptibility to infections and their severity. Clinical presentation of infections may be atypical and presentation of serious infections may be masked. Chickenpox and herpes zoster are of particular concern. Passive immunisation needed within 10 days in exposed non-immune patients taking systemic glucocorticosteroids. Urgent specialist care required on confirmed chickenpox. Give normal immunoglobulin immediately after measles exposure. Do not give live vaccines to those with chronic glucocorticosteroid use. Antibody

response to other vaccines may be diminished. With severe liver function disorders: increased systemic bioavailability. Central serous chorioretinopathy or other causes may result in blurred vision/visual disturbances. Consider referral to ophthalmologist. Suppression of the HPA axis and reduced stress response: supplementary systemic glucocorticoid treatment may be needed. Avoid concomitant treatment with CYP3A4 inhibitors. Do not use in patients with galactose or fructose intolerance, glucose – galactose malabsorption, sucrase – isomaltase insufficiency or Lapp lactase deficiency or congenital lactase deficiency. In autoimmune hepatitis evaluate transaminase levels every 2 weeks for the first month and then every 3 months. Interactions: Co-treatment with CYP3A inhibitors including cobicistat containing products may increase side effects and should be avoided where possible. Beware concomitant administration of cardiac glycosides and saluretics. CYP3A4 inhibitors: avoid concomitant administration. CYP3A4 inducers: may reduce systemic and local exposure, necessitating dose adjustment of budesonide. CYP3A4 substrates: may compete with budesonide increasing plasma concentrations depending on relative affinities. Small, non-significant effect of cimetidine on budesonide kinetic effects. Oestrogens/oral contraceptives may elevate plasma concentrations and enhance corticosteroid effects. Steroid-binding compounds and antacids may reduce budesonide efficacy; administer at least 2 hours apart. Because adrenal function may be supressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Use in pregnancy and lactation: Avoid use in pregnancy unless essential. Do not breastfeed during Budenofalk treatment. Undesirable effects: Cushing’s syndrome, growth retardation in children, glaucoma, cataracts, blurred vision, dyspepsia, abdominal pain, constipation, gastric or duodenal ulcers, pancreatitis, increase in risk of infections, muscle and joint pain and weakness and twitching, osteoporosis, osteonecrosis, headache, pseudotumor cerebri (including papilloedema) in adolescents, depression, irritability and euphoria,

www.drfalk.co.uk Dr Falk Pharma UK Ltd, Unit K, Bourne End Business Park, Cores End Rd, Bourne End, SL8 5AS. Registered in England No: 2307698

psychomotor hyperactivity, anxiety, aggression, allergic exanthema, petechiae, ecchymosis, contact dermatitis, delayed wound healing, increased risk of thrombosis, vasculitis (after withdrawal from longterm treatment), fatigue, malaise. Side effects characteristic of systemic glucocorticosteroid therapy may occur. Exacerbation or reappearance of extraintestinal manifestations when switching from systemically acting glucocorticosteroids may occur. Frequency is likely to be lower than with equivalent dosage of prednisolone. Legal category: POM. Costs: UK NHS: 60 sachets £135.00; 100 capsules £75.05. Ireland (PtW): 60 sachets: €149.49; 100 capsules: €78.96. Licence holder: Dr Falk Pharma GmbH, Leinenweberstr.5, D-79108 Freiburg, Germany. Licence numbers: (granules) PL08637/0020 (UK) PA573/2/3 (IE) (capsules) PL08637/0002 (UK) PA573/2/1 (IE). Prepared: February 2019. Further information available on request. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play, Apple App Store (UK residents) or at email: medsafety@hpra.ie or at http://www.hpra.ie/homepage/ about-us/report-an-issue/human-adverse-reaction-form (residents in Ireland). Adverse events should also be reported to Dr Falk Pharma UK Ltd. References: 1. Bar-Meir S et al. Gastroenterol 1998; 115(4): 835-40. 2. De Cassan C et al. Dig Des 2012; 30(4): 368-75. 3. Czaja AJ. Dig Dis Sci 2012; 57(8): 1996-2010. 4. Miehlke S et al. Gastroenterol 2002; 123(4): 978-84. DrF19/003 Date of preparation: March 2019

EDITORS COMMENT

EDITORS COMMENT Seek and ye shall find

“As with all rare diagnoses, the critical first step is to consider it.”

The case-report by Arakkal et al. included in this edition of Gastroenterology Today presents a rare cause of a common presentation, and highlights the importance of including these in the differential diagnosis. Arakkal et al. describe a case of acute upper GI bleeding secondary to primary aortoenteric fistula. The diagnosis of primary aorto-enteric fistula requires cross-sectional imaging, which does not form part of the GI bleeding pathway in most international guidelines. These patients could exsanguinate whilst awaiting their colonoscopy or video capsule endoscopy, the two investigations usually advocated after negative upper GI endoscopy. If this rare diagnosis had not been considered, and the CT scan requested, then the diagnosis could not have been made. Early identification of patients with aorto-enteric fistula is paramount, as it is common to present with a smaller herald bleed prior to catastrophic GI haemorrhage. Presenting symptoms are non-specific. Routine physical examination is only moderately sensitive for detecting abdominal aortic aneurysm (AAA), even when the physical examination is directed specifically to the detection of AAA. In contrast, ultrasound and CT imaging are highly sensitive. Could there be a role for focussed ultrasound scanning in the emergency department for at-risk patients who present with GI bleeding, such as those aged over 60 years? As with all rare diagnoses, the critical first step is to consider it.

Dr Ben Shandro Research Fellow in Gastroenterology St George’s Hospital

GASTROENTEROLOGY TODAY - SUMMER 2019

CASE REPORT

PRIMARY AORTO-ENTERIC FISTULA A CASE REPORT 1. Dr Mohammed Shaheer Pandara Arakkal, Senior Clinical Fellow , Gastroenterology, Morriston hospital, Swansea Wales, UK 2. Dr.Umakant Dave, Consultant Gastroenterologist, , Morriston Hospital, Swansea Wales, UK 3. Victoria Trainer, Consultant Radiologist, Singleton Hospital, Swansea Wales, UK

Abstract Aorto-enteric fistula is a life threatening condition and is defined as an abnormal communication between the abdominal aorta and gastrointestinal tract. It is most often secondary to either erosion of an aortic prosthetic graft or other vascular procedure on the aorta, known as secondary aorto-enteric fistulae (SAEF). Primary aorto-enteric fistula (PAEF) occurs as a result of compression of an abdominal aortic aneurysm (AAA) against the surrounding gastrointestinal structures causing spontaneous communication between them. We describe a case of PAEF in an 85 year old woman who was known to have AAA who presented with acute upper gastrointestinal haemorrhage to the emergency department. This report

as a complication of endovascular procedures with prosthesis or stent graft or a surgical procedure usually for an AAA repair. Primary aortoenteric fistula (PAEF) is a rare but serious differential diagnosis that must be considered in any patients who presents with upper gastro intestinal (GI) haemorrhage, especially if the patient is known to have an abdominal aortic aneurysm (AAA). Although aorto-enteric fistula (AEF) has several aetiologies, the most common cause of PAEF is AAA. As PAEF is quite a challenging diagnosis for the treating physician, early detection and treatment is vital for the patient survival. If left untreated mortality is 100%. This is a case report of a patient with known AAA who was found to have Aorto- duodenal fistula while investigating for Upper GI haemorrhage.

highlights the importance of high index of suspicion in diagnosing aortoenteric fistula, especially if the patient is known to have AAA.

Introduction

Case Report An 85 year old lady presented to the Emergency department (ED) in October 2018 with two episodes of haematemesis and one episode melaena. She had a further episode of melaena in the ED. She had a

Primary aorto-enteric fistula (PAEF) is an abnormal communication

background history of coronary artery bypass graft (CABG) in 1993, chronic

between abdominal aorta and gastrointestinal (GI) tract in the absence of

obstructive pulmonary disease (COPD), osteoporosis, varicose eczema

any vascular intervention on aorta. Secondary aorto-enteric fistula occurs

and high cholesterol. She was an ex-heavy smoker with a 50 pack-year smoking history and consumed alcohol occasionally. No previous history of upper GI haemorrhage. Her regular medications were Co-Codamol, Alendronic acid, Lansoprazole, Oxybutynin, Gabapentin, GTN spray, Isosorbide mononitrate, Paroxetine, Diltiazem, Aspirin and Atorvastatin. Three months prior to the last admission she presented to the ED after a fall and sustained a fracture dislocation of the left shoulder. A chest X-ray then showed a small density in the left upper zone measuring approximately 12mm. She underwent surgery for her fracture and was

GASTROENTEROLOGY TODAY - SUMMER 2019

discharged from the hospital. An outpatient CT thorax and abdomen performed two months later to evaluate the lung mass incidentally revealed a 6.4 cm abdominal aortic aneurysm, which extended down to the bifurcation. The descending thoracic aorta was also aneurysmal [Image 1]. The mass in the lung was reported as possible fibrosis. She was referred to vascular surgeons for further management of AAA. A decision was made by the vascular surgery team not to intervene because of the morphology of aneurysm, as well as patientâ&#x20AC;&#x2122;s age, comorbidities and frailty. Blood results during the last admission with GI haemorrhage revealed an Hb of 94 g/L (112 g/L when discharged home from previous admission), white cell count of 34.1 x10^9/L (neutrophil count 30.8 Image [1] CT image on previous admission showing A-Abdominal Aortic Aneurysm (AAA) belly. B-Duodenum clinging around the aortic aneurysm, but no gas with in the aneurysm Image 1

x10^9/L), platelet count of 352 x10^9/L, MCV of 90 fL. U&Es revealed Na-143 mmol/L, K-4.5 mmol/L, Urea 8.6 mmol/L, creatinine 95 umol/L, CRP-20 mg/L, normal LFTs and normal clotting parameters.

CASE REPORT

You’ve probably never seen an oral iron like FERACCRU® before For the treatment of adults with iron deficiency anaemia (IDA)1

Before starting treatment, iron defi ciency or iron defi ciency anaemia (IDA) diagnosis should be made based on blood tests; it is important to investigate the cause of the iron defi ciency and to exclude underlying causes of anaemia other than iron defi ciency. Feraccru contains lactose and so patients with rare hereditary problems of galactose intolerance, total lactase defi ciency or glucose-galactose malabsorption should not take this medicine. This product also contains Allura Red AC (E129) and Sunset Yellow FCF (E110); these may cause allergic reactions. Interactions: Food has been shown to inhibit uptake of Feraccru and so Feraccru should be taken on an empty stomach. Avoid concomitant administration of Feraccru and IV iron, dimercaprol, chloramphenicol and methyldopa. Feraccru should be given at least 2 to 3 hours apart from: penicillamine, bisphosphonates, ciprofl oxacin, entacapone, levodopa, levofl oxacin, levothyroxine (thyroxine), moxifl oxacin, mycophenolate, norfl oxacin, ofl oxacin, tetracyclines, calcium and magnesium salts e.g. magnesium trisilicate. Fertility, pregnancy and lactation: There are no data from the use of Feraccru in pregnant or breast-feeding women. Ferric maltol is not available systemically and is therefore unlikely to pass into the mother’s milk. As a precautionary measure, it is preferable to avoid the use of Feraccru during pregnancy and breast-feeding. There are no data on the effect of ferric maltol on human fertility. Undesirable effects: Common side effects: Abdominal pain, fl atulence, constipation, abdominal discomfort/distension, and diarrhoea. Refer to the SmPC for a full list and frequency of adverse events. Price and pack sizes: Basic NHS price:

£47.60 for 56 capsules. Legal category: Prescription Only Medicine. Marketing Authorisation Number: EU/1/15/1075/001 Marketing Authorisation Holder: Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands. Date of preparation: February 2019 For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefi eld, Middlesex, United Kingdom UB9 6NS. Telephone: +44(0)1895 826606. E-mail: medinfo@norgine.com. Company reference: UK/FER/0219/0045

United Kingdom - Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Norgine Pharmaceuticals Ltd on: Tel. +44 (0)1895 826 606 E-mail medinfo@norgine.com FERACCRU is a registered trademark of the Shield group of companies, licensed to the Norgine group of companies. NORGINE and the sail logo are registered trademarks of the Norgine group of companies. Reference: 1. FERACCRU® Summary of Product Characteristics. January 2019. Date of preparation: March 2019. UK/FER/0219/0033.

GASTROENTEROLOGY TODAY - SUMMER 2019

PRESCRIBING INFORMATION: Feraccru 30mg hard capsules (ferric maltol) Please refer to the full Summary of Product Characteristics (SmPC) before prescribing. Presentation: Red hard capsules. Each capsule contains 30 mg iron (as ferric maltol). Indication: Feraccru is indicated in adults for the treatment of iron defi ciency. Dosage and Administration: Adults: Feraccru should be taken orally. The whole capsule should be taken on an empty stomach (with half a glass of water). The recommended dose is one capsule twice daily, in the morning and evening. The absorption of iron is reduced when Feraccru is taken with food. Treatment duration will depend on the severity of iron defi ciency but generally at least 12 weeks treatment is required. The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests. Elderly: No dose adjustment is necessary. Children: The safety and effi cacy of Feraccru in children (17 years and under) has not yet been established. No data are available. Patients with hepatic or renal impairment: No clinical data is available in this patient population. Contraindications: Hypersensitivity to the active substance or to any of the excipients; Haemochromatosis and other iron overload syndromes; Patients receiving repeated blood transfusions. Warnings and precautions: Feraccru should not be used in patients with infl ammatory bowel disease (IBD) fl are or in IBD patients with haemoglobin (Hb) levels <9.5g/dL. Iron preparations in excess may cause toxicity especially among children and so Feraccru must not be administered to children. Take special care when used with other dietary and/or iron salt supplementation.

CASE REPORT Examination revealed HR-95 b/m, BP 130/70 mm Hg, oxygen saturation

400 of PAEF cases have been reported up until now [2&3]. PAEF is a

96% on 2 Litres of oxygen and normal temperature. Abdominal

potentially fatal and a rare complication of untreated aortic aneurysm,

examination revealed a large pulsatile abdominal mass. PR examination

which warrants a high index of clinical suspicion when presented with

revealed melaena on glove. She scored 10 points on the Glasgow-

upper GI haemorrhage. The fistula most commonly erodes into an

Blatchford Bleeding Score.

area of intestine (most commonly the third part of duodenum) which has close contact with the pulsating aortic segment [4, 5&6]

After resuscitation with IV fluids and blood products the patient was transferred to the ward. She had 3 further large episodes of melaena on the same day and was taken to the endoscopy unit for upper GI endoscopy which did not reveal blood in the upper GI tract, but did show a deep ulcer in the second part of duodenum (D2) [Image 2&3]. Post- endoscopy Rockall Score was 6. The consultant who performed the endoscopy was concerned about the morphology of the ulcer and recommended a CT scan and urgent surgical review to rule out a primary aorto-enteric fistula [PAEF]. In view of high suspicion of a PAEF, the endoscopist elected not to perform endotherapy used for bleeding duodenal ulcer. A 3 phase CT abdomen and pelvis revealed an increase in size of the infrarenal abdominal aortic aneurysm [AAA] which measured 8 cm [Image 4] (6.4cm previously [Image 1]). New gas locules within the inferior aspect of aneurysm sac were highly suggestive of aorto-enteric fistulation. The aortic sac was inseparable

The classical triad of symptoms with abdominal pain, pulsatile abdominal mass and gastrointestinal haemorrhage are only found in 6-12% of patients [7&8]. The most common presentation is upper GI haemorrhage. Often the initial GI bleeding is small (herald bleed), but one third of the patients presents with massive recurrent bleeding within 6 hours [9]. Many patients with aorto-enteric fistula (AEF) die before an accurate diagnosis is made due to its variable clinical manifestations and insufficient awareness of this rare entity among non-specialty clinicians. Although literature review suggests the most common aetiology for PAEF are atherosclerotic and traumatic AAA, other causes include radiation, cancer, metastasis, gallstone erosion, ulcers, diverticulitis appendicitis, aortitis, infections like TB, pancreatic pseudo cyst penetration and foreign body ingestion[10&3].

from the proximal duodenum and tracking gas locules were suggestive of a communication between aneurysm sac and second part of

Unusual features of this case include the fistulous connection between

duodenum [Image 4]. An urgent vascular review was requested and

the AAA and second part of duodenum and the presence of a deep

vascular surgeons decided not to surgically intervene as the patient

ulcer on endoscopy. Even though no literature is available to confirm,

was very frail and unlikely to survive a repair. This was discussed with

it is possible that standard endotherapy for bleeding duodenal ulcer

the patient and her daughter and decision for palliation was made. The

(adrenaline injection, heater probe, gold probe coagulation and

patient had another massive haematemesis and melaena early in the

endoclip placement) may lead to massive haemorrhage in patients

morning of the next day and died after a few hours.

with aorto-enteric fistula. In our patient, possibility of PAEF was considered very high and endotherapy was not attempted.

Discussion

Though less frequent, there are reports in literature that described

Formation of fistula between aorta and intestinal tract was first described

as the oesophagus, jejunum, ileum and colon, but most of these were

by an English Surgeon Sir Ashley Cooper in 1829 [1]. But the first case

secondary to endovascular or other surgical procedures on aorta

report of PAEF was published by Salmon in 1843. Since then only about

causing secondary fistulation [11].

GASTROENTEROLOGY TODAY - SUMMER 2019

Image 2

abnormal communication between aorta and other pat of GI tract such

Image [2] A-Endoscopic view of deep ulcer in D2

Image [3] A-Endoscopic view of deep ulcer in D2

Image 3

Life feels good when they’re underCASE control REPORT

1-8

CROHN’S DISEASE Indicated for the induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon9

ULCERATIVE COLITIS Indicated for ulcerative colitis involving rectal and recto-sigmoid disease10

MICROSCOPIC COLITIS

Indicated for the induction and maintenance of remission in patients with microscopic colitis9

LY ® R is the ON Entocort C T N E M TREAT LICENSED d an n ctio for the indu of remission ce an en nt 9 ai m ic colitis in microscop insomnia, mood swings and depression, palpitations, dyspepsia, skin reactions (urticaria, exanthema), muscle cramps, menstrual disorders. Uncommon: anxiety, tremor, psychomotor hyperactivity. Rare: aggression, glaucoma, cataract, blurred vision, ecchymosis. Very rare: Anaphylactic reaction, growth retardation. Prescribers should consult the summary of product characteristics in relation to other adverse reactions. Marketing Authorisation Numbers, Package Quantities and basic NHS price: PL 36633/0006. Packs of 100 capsules: £84.15. Legal category: POM. Marketing Authorisation Holder: Tillotts Pharma UK Ltd, The Stables, Wellingore Hall, Wellingore, Lincoln, LN5 0HX. Date of preparation of PI: November 2018 ENTOCORT (budesonide) ENEMA - Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing Information Presentation: 0.02 mg/ml budesonide (2 mg budesonide/100 ml) solution for rectal suspension. Each Entocort Enema consists of 2 components: a 2.3 mg faintly yellow, circular biconvex tablet with the engraving BA1 on one side and 2.3 on the other side; a 115 ml clear colourless solution. Indications: Ulcerative colitis involving rectal and recto-sigmoid disease. Dosage and administration: Route of administration: rectal. Adults: One Entocort Enema nightly for 4 weeks. Full effect is usually achieved within 2–4 weeks. If the patient is not in remission after 4 weeks, treatment may be prolonged to 8 weeks. Paediatric population: Not recommended. Older people: Dosage as for adults. No dosage reduction in patients with reduced liver function. Instruct the patient to read the instructions for use. Reconstitute the enema immediately before use. Ensure the tablet is completely dissolved. Administer in the evening before bed. Contraindications: Hypersensitivity to the active substance or the excipients. Warnings and Precautions: Side effects typical of corticosteroids may occur, including glaucoma. Visual disturbances may occur. If a patient presents with symptoms such as blurred vision or other visual disturbances they should be considered for referral to an ophthalmologist for evaluation. When patients are transferred from steroids of higher systemic effect they may have adrenocortical suppression; monitoring may be considered and the dose of systemic steroid should be reduced cautiously. Replacement of high systemic effect steroid treatment with Entocort enema sometimes unmasks allergies which were previously controlled by the systemic drug. Reduced liver function affects the elimination of glucocorticosteroids, causing lower elimination rate and higher systemic exposure, with possible systemic side effects. Care when considering systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or first degree relatives e.g. depressive or manic-depressive illness and previous steroid psychosis. Systemic effects of steroids may occur, particularly at high doses and for prolonged periods, including Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and very rarely a wide range of psychiatric/behavioural effects. Contains lactose and methyl-, propyl-parahydroxybenzoate. Caution in patients with hypersensitivity to these. Some patients may feel unwell in a non-specific way during withdrawal.

When Entocort Enema is used chronically in excessive doses, systemic glucocorticosteroid effects may appear. However, the dosage form and the route of administration make any prolonged overdosage unlikely. Interactions: Raised plasma concentrations and enhanced effects of corticosteroids have been reported in women also treated with oestrogens and contraceptive steroids. Inhibitors of CYP3A4 can increase systemic exposure to budesonide several times and the combination should be avoided. If this is not possible, the period between treatments should as long as possible, and a reduction of the budesonide dose could also be considered. Other potent inhibitors of CYP3A4 are also likely to markedly increase plasma levels of budesonide. Concomitant treatment with CYP3A4 inducers may reduce budesonide exposure and require a dose increase. Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show low values. Fertility, pregnancy and lactation: Only to be used during pregnancy when the potential benefits to the mother outweigh the risks for the foetus. May be used during breast feeding. Adverse reactions: Common: depression, gastrointestinal disturbances (flatulence, nausea, diarrhoea), skin reactions (urticaria, exanthema). Uncommon: agitation, insomnia, anxiety, psychomotor hyperactivity, duodenal or gastric ulcer. Rare: signs or symptoms of systemic glucocorticosteroid effects, aggression, glaucoma, cataract including subcapsular cataract, blurred vision, pancreatitis, ecchymosis, osteonecrosis. Very rare: anaphylactic reaction. Prescribers should consult the summary of product characteristics in relation to other adverse reactions. Marketing Authorisation Numbers, Package Quantities and basic NHS price: PL 36633/0007. Packs of 7 enemas: £33.66. Legal category: POM. Marketing Authorisation Holder: Tillotts Pharma UK Ltd, The Stables, Wellingore Hall, Wellingore, Lincoln, LN5 0HX. Date of preparation of PI: March 2018

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse events should also be reported to Tillotts Pharma UK Ltd. Tel: 01522 813500. References: 1. Greenberg GR et al. N Engl J Med 1994;331:836-841. 2. Rezaie A et al. Cochrane Database Syst Rev 2015;6:CD000296. 3. Madisch A et al. Int J Colorectal Dis 2005;20(4):312-316. 4. Hofer KN. Ann Pharmacother 2003;37:1457-1464. 5. Miehlke S et al. Gastroenterology 2008;135:1510-1516. 6. Gross V et al. Aliment Pharmacol Ther 2006;23:303312. 7. Hartmann F et al. Aliment Pharmacol Ther 2010;32(3):368-376. 8. Danielsson A et al. Scand J Gastroenterol 1992;27(1):9-12. 9. Entocort® CR 3mg Capsules – Summary of Product Characteristics. November 2018. 10. Entocort® Enema – Summary of Product Characteristics. March 2018. Date of preparation: December 2018. PU-00225.

GASTROENTEROLOGY TODAY - SUMMER 2019

ENTOCORT CR 3mg Capsules (budesonide) - Prescribing Information Please consult the Summary of Product Characteristics (SmPC) for full prescribing Information Presentation: Hard gelatin capsules for oral administration with an opaque, light grey body and an opaque, pink cap marked CIR 3mg in black radial print. Contains 3mg budesonide. Indications: Induction of remission in patients with mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon. Induction of remission in patients with active microscopic colitis. Maintenance of remission in patients with microscopic colitis. Dosage and administration: Active Crohn’s disease (Adults): 9mg once daily in the morning for up to eight weeks. Full effect achieved in 2-4 weeks. When treatment is to be discontinued, dose should normally be reduced in final 2-4 weeks. Active microscopic colitis (Adults): 9mg once daily in the morning. Maintenance of microscopic colitis (Adults): 6mg once daily in the morning, or the lowest effective dose. Paediatric population: Not recommended. Older people: No special dose adjustment recommended. Swallow whole with water. Do not chew. Contraindications: Hypersensitivity to the active substance or any of the excipients. Warnings and Precautions: Side effects typical of corticosteroids may occur. Visual disturbances may occur. If a patient presents with symptoms such as blurred vision or other visual disturbances they should be considered for referral to an ophthalmologist for evaluation of the possible causes. Systemic effects may include glaucoma and when prescribed at high doses for prolonged periods, Cushing’s syndrome, adrenal suppression, growth retardation, decreased bone mineral density and cataract. Caution in patients with infection, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts or with a family history of diabetes or glaucoma. Particular care in patients with existing or previous history of severe affective disorders in them or their first degree relatives. Caution when transferring from glucocorticoid of high systemic effect to Entocort CR. Chicken pox and measles may have a more serious course in patients on oral steroids. They may also suppress the HPA axis and reduce the stress response. Reduced liver function may increase systemic exposure. When treatment is discontinued, reduce dose over last 2-4 weeks. Concomitant use of CYP3A inhibitors, such as ketoconazole and cobicistat-containing products, is expected to increase the risk of systemic side effects and should be avoided unless the benefits outweigh the risks. Excessive grapefruit juice may increase systemic exposure and should be avoided. Patients with fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take Entocort CR. Monitor height of children who use prolonged glucocorticoid therapy for risk of growth suppression. Interactions: Concomitant colestyramine may reduce Entocort CR uptake. Concomitant oestrogen and contraceptive steroids may increase effects. CYP3A4 inhibitors may increase systemic exposure. CYP3A4 inducers may reduce systemic exposure. May cause low values in ACTH stimulation test. Fertility, pregnancy and lactation: Only to be used during pregnancy when the potential benefits to the mother outweigh the risks for the foetus. May be used during breast feeding. Adverse reactions: Common: Cushingoid features, hypokalaemia, behavioural changes such as nervousness,

CASE REPORT The diagnosis of aorto-enteric fistula typically is delayed, as long as 1 month in 50% of patients in one series, with the diagnosis being made within 10 days of hospitalization in only 15% of cases [12]. Urgent upper GI endoscopy is important for exclusion of common causes of massive upper GI bleeding; but the diagnostic sensitivity for aorto-enteric fistula has been reported to be as low as 25% [12]. Gastrointestinal bleeding with endoscopically unclear findings in a patient with aortic aneurysm or history of aortic repair should points towards an aorto-enteric fistula [13]. The most valuable tool for diagnosing AEF is a CT scan with contrast, which may reveal gas within the aneurysm, destruction of the fat plane between the aneurysm and duodenum, proximity and connection between aorta and intestine and leaking of the contrast into the GI lumen; all highly suggestive of AEF [14]. MRI is less useful because of its limited availability in the emergency setting, longer acquisition time, need for local technical expertise, and potential difficulties differentiating peri-graft gas from aortic wall calcification. All other investigation modalities like white blood cell scan are of limited value in diagnosing AEF. Percutaneous angiography has a sensitivity of 94 percent and a specificity of 85 percent for detecting aorto-enteric fistula (AEF); but is rarely considered as most patients are critically ill by the time of a decision is made to do it [15&16]. ]. A high index of suspicion is paramount, supplemented by the judicious use of upper endoscopy and CT, and the attending physician must be willing to recommend exploratory laparotomy if clinical suspicion is sufficiently high. As immediate and correct diagnosis is difficult, the mortality is very high and an untreated AEF has 100% mortality. Mortality of invasively treated patients is approximately 50 %. [17].

Conclusion Although AEF is an extremely rare cause of upper GI haemorrhage, it must always be considered and ruled out in GI haemorrhages. A herald

bleed followed by a an endoscopy is usually the first step in diagnosis. This case highlights the importance of high index of suspicions in diagnosing AEF, especially if the patient is known to have AAA. PAEF is rare if the patient is not known to have AAA; but an accurate clinical evaluation to rule out an abdominal bruit or pulsatile mass should be done to rule out AEF. AEF is potentially fatal. An early diagnosis with prompt surgical management has huge prognostic benefits. References 1. Cooper A. Lectures on the Principles and Practice of Surgery, London 1829 2. Abdu Hassan Alzobydi and Shaista Salman Guraya. Primary aortoduodenal fistula: A case reportWorld J Gastroenterol. 2013 Jan 21; 19(3): 415–417.Published online 2013 Jan 21. doi: 10.3748/wjg.v19.i3.415 3. Daniele Bissacco, Luca Freni, Luca Attisani, Iacopo Barbetta, Raffaello Dallatana, and Piergiorgio Settembrini. Unusual clinical presentation of primaryaortoduodenal fistula. Gastroenterol Rep (oxf). 2015 may; 3(2): 170–174. Published online 2014 Jun 30. doi: 10.1093/gastro/gou040 4. Jarboui S, Jarraya H, Mahjoub W, Baccar M, Kacem C, Abdesselem MM, Zaouche A. Primary aorto-enteric fistula in a 52-year-old man. Tunis Med. 2008 Sep; 86(9):830-2. 5. Debonnaire P, Van Rillaer O, Arts J, Ramboer K, Tubbax H, Van Hootegem P. Primary aorto enteric fistula: Report of 18 Belgian cases and literature review. Acta Gastroenterol Belg. 2008 Apr-Jun; 71(2):250-8. 6. O’Mara C, Imbembo AL. Paraprosthetic-enteric fistula. Surgery. 1977 May; 81(5):556-66. 7. Calligaro KD, Bergen WS, Savarese RP, Westcott CJ, Azurin DJ, Delaurentis DA. Primary aortoduodenal fistula due to septic aortitis. J Cardiovasc Surg (Torino). 1992 Mar-Apr; 33(2):192-8. 8. Voorhoeve R,Moll FL, De letter JA, Bast TJ Wester JP, Slee PH. Primary aortoenteric fistula: Report of eight new cases and review of the literature. Ann Vasc Surg. 1996 Jan; 10(1):40-8. 9. Fernández de Sevilla E, Echeverri JA, Boqué M, Valverde S, Ortega N, Gené A, Rodríguez N, Balibrea JM, Armengol M. Life-threating upper gastrointestinal bleeding due to a primary aorto-jejunal fistula. Int J Surg Case Rep. 2015; 8C:25-8. doi: 10.1016/j. ijscr.2015.01.010. Epub 2015 Jan 9. 10. Sharma K, Kibria R, Ali S, Rao P. Primary aortoenteric fistula caused by an infected abdominal aortic aneurysm with Mycobacterium avium complex in an HIV patient. Acta Gastroenterol Belg. 2010 Apr-Jun; 73(2):280-2. 11. Sin-Jae Kang, Dong-LK, Kim, Se-Ho Huh, Byung-Boong Lee, Duk-Kyung Kim, and Young-Soo Do. Coexisting aortocolic and aortovesical fistulae in an abdominal aortic aneurysm: Report of a case. Surgery today. June 2003, Volume 33, Issue 6, pp 441–443. 12. Pipinos II, Carr, J.A., Haithcock, B.E., Anagnostopoulos, P.V., Dossa, C.D., and Reddy, D.J. Secondary aorto-enteric fistula. Ann Vasc Surg. 2000; 14: 688–696). 13. Franke S, Debus ES, Voit R. Aorto-intestinal fistula as a possible cause of endoscopically undetermined gastrointestinal hemorrhage. [Article in German]. Chirurg. 1995 Feb; 66(2):112-9

GASTROENTEROLOGY TODAY - SUMMER 2019

14. Saers SJ, Scheltinga MR. Diagnostic image (154). A man with haematemesis and gas in the aorta. Primary aorto-enteric fistula. [Article in Dutch]. Ned tijdschr geneeskd. 2003 Aug 30; 147(35):1686 15. Yeong KY. Angiographic demonstration of primary aorto-enteric fistula--A case report. Ann Acad Med Singapore. 1995 May; 24(3):467-9. 16. Huges FM1, Kavanagh D Barry M, Owen A, Macerlaine DP, Malone de, Aortoenteric Fistula: a diagnostic dialemma. Abdom imaging.2007 May-Jun; 32(3):398-402.epub 2006 Aug 25 17. Behrendt CA, Wipper S, Debus SE, von Kodolitsch Y, Püschel K, Kammal M, Kammal A. Primary aorto-enteric fistula as a rare cause of massive gastrointestinal haemorrhage. Vasa. 2017 Oct; 46(6):425-430. doi: 10.1024/0301-1526/a000646. Epub 2017 Jun 30. Image [4] Coronal reconstruction on this portal venous CT study demonstrates A-Abdominal Aortic Aneurysm (AAA) belly which has increased in size compared to previous CT image B-New gas locule within the inferior aspect of aneurysm sac C-Inseparable aortic sac from the proximal duodenum and tracking gas locules suggestive of a communication between aneurysm sac and second part of duodenum Image 4

Consent for Publication Written consent obtained Address for correspondence Dr Mohammed Shaheer Pandara Arakkal, Senior Clinical fellow in Gastroenterology, House G, Morriston Hospital, Swansea SA6 6NL

FEATURE

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www.symprove.com/bioscience References: 1. Freuda-Agyeman, M et al. (2014). Comparative survival of commercial probiotic formulations: tests in biorelevant gastric fluids and real-time measurements using microcalorimetry. Beneficial Microbes. 6(1). 141-151 2. Data on file. Results from a SymproveTM Customer Survey 3. Wang, B et al. (2017). The human microbiota in health and disease. Engineering 3(1). 71-82 4. Sisson G, Ayis S, Sherwood RA and Bjarnason I. (2014). Randomised clinical trial: A liquid multi-strain probiotic vs. placebo in the irritable bowel syndrome – a 12 week double-blind study. Aliment Pharmacol Ther 40. 51-62

GASTROENTEROLOGY TODAY - SUMMER 2019

 Bacteria are clinically proven to rapidly colonise in the gut, contributing to gut microbiome balance

Dr. Daniel Vinteler CEO and Founder of Plasmabiotics, invented the PlasmaTYPHOON and PlasmaBAG; a device designed to minimize the risk of bacterial contamination in endoscopy. Daniel Vinteler has been in close contact with patients from the very beginning. This has provided him with a comprehensive understanding of the hygiene risks in endoscopy and this revolutionary new way to reduce them.

‘Drying is a possible pitfall for hygiene in endoscopy’ The diagnostic and therapeutic utility of Endoscopic Retrograde Cholangio-Pancreatography (ERCP) has been well demonstrated for a variety of disorders, such as the management and treatment of biliopancreatic diseases. Due to their complex design, duodenoscopes have been long recognized to require thorough processes and precise execution to properly disinfect. As the importance of ERCP procedures and their impact on patients’ lives remains unwavering. We speak to Dr. Daniel Vinteler (PlasmaBiotics) and Ulrike Beilenhoff (ESGENA) about their ideas concerning the challenges and solutions for the future of endoscopy and PlasmaBiotics latest technology, the PlasmaTYPHOON. How important is it to raise awareness about the risk of infection, during endoscopy procedures in a cross functional way? Ulrike Beilenhoff: Hygiene is an important concern as it relates to patient’s safety. Hospitals have the task to ensure a safe environment in order to prevent any adverse events and complications. The patient is in a vulnerable situation, they may have existing health problems, they are undergoing an endoscopy procedure, and when you expose the patient to additional germs, you create an additional risk. Since the early 2000s we are experiencing problems with multidrug resistant bacteria. If a patient is ill and subsequently exposed to this bacteria, hospitals have limited options to treat the patient. The aim is to avoid any additional risk and therefore hygiene is really a core focus in this commitment. Thus, establishing hygiene as a commitment to the patient’s safety.

What are the hygiene issues inherent to endoscope handling and storage? Daniel Vinteler: Every step of endoscope reprocessing is crucial to ensure a hygienic procedure: the pre-cleaning, cleaningdisinfection, drying and storage. If one of these steps is not performed correctly, hygiene is not guaranteed. In practice, the drying of the endoscope is often underestimated and therefore a possible pitfall for hygiene and reprocessing steps. If the scope is not dried properly, all the steps before are undercut. Why is it so crucial to dry an endoscope after the device has been disinfected? Ulrike Beilenhoff: Publications showed that several outbreaks have been caused by insufficient dyring. If you do not clean the endoscope properly then you leave residual debris. If you do not dry the endoscope it creates a perfect environment to breed

germs. Nurses are aware of both of these steps. A perfectly dried endoscope stops bacterial proliferation. What are the key challenges and constraints in endoscope drying and storage? Why are these steps sometimes not perfectly carried out? Ulrike Beilenhoff: Time constraints in hospitals present challenges to effective drying and storage. Surveys showed that nurses and reprocessing staff work under time pressure. Even though they are aware of the importance of thorough cleaning and drying, it can be challenging. Sufficient time is the prerequisite for correct reprocessing of endoscopes and this also includes sufficient time for drying before storage. It is the responsibility of hospitals as service providers to ensure a proper training for all staff involved in endoscope reprocessing.

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Nurses are not the only individuals working in scope reprocessing. If staff are not trained to understand the endoscope channels in detail, they may struggle to effectively dry the endoscope. How does the PlasmaTYPHOON device completely dry an endoscope? Daniel Vinteler: The PlasmaTYPHOON offers a new way to dry and store the scope with plasma, thereby reducing the risk of contamination. The drying process with the PlasmaTYPHOON is managed by a patented curve of pressure. The unit uses a laminar flow to eliminate the water and a turbulent heated flow to dry the walls. At PENTAX Medical we are committed to addressing the hygiene challenges in endoscopy by offering solutions that minimize the risk of infections, improve clinical

outcomes, enhance provider experience, and increase healthcare productivity. We are actively listening to our customers and stakeholders, so we understand the complexity of the procedures and the risk of infection. How does the system improve on existing solutions? What advantages can staff expect while using the PlasmaTYPHOON? Daniel Vinteler: The PlasmaTYPHOON is the first solution to guarantee a dry endoscope in up to 5 minutes1 (the drying time depends on the endoscope type), and storage up to 31 days2,3 in a fully controlled environment. The advantages for staff are numerous and include saving time and space, cost reductions, mobility of the scopes while they are stored in the PlasmaBAG, and of course an improved level of hygiene.

What advantage do you foresee in a system such as the PlasmaTYPHOON and BAG, which dries the scope perfectly in an automatized way and stores the scope in a protected environment? Ulrike Beilenhoff: Hospitals need an easy and fast system to dry endoscopes. Often medical professionals cannot visibly see that the endoscope is wet, as the exterior appears dry, thus presenting a hygiene challenge. Daniel Vinteler: The PlasmaTYPHOON offers a solution to these challenges, by perfectly drying the endoscope and doing so in an easy and fast manner. The PlasmaTYPHOON is the most advantageous option for endoscope reprocessing as it completes the task quickly and easily, without compromising effectiveness.

1. Evaluation of the efficacy of a drying unit for internal channels of endoscopes according to NF S98-030- Test Report by Biotech-Germande February 2015. 2. Evaluation of the ability of a storage system (Plasmabiotics) to maintain the microbiological quality of heat sensitive endoscope. Report by Biotech-Germande April 2017. 3. The maximum storage time may be subject to local regulations on endoscope storage. The country regulation can restrict the maximum storage time to 7 days. Please refer to the relevant regulations or recommendation of your country.

Ulrike Beilenhoff, Scientific Secretary and former President of the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA). Ulrike has important insights concerning the hygiene challenge in endoscopy; specialized in endoscopy nursing, with 16 years of experience as head nurse in German Endoscopy Departments.

FEATURE

SHOWING THE TRUE VALUE OF PROBIOTICS – UNDERSTANDING THE SCIENCE AND HISTORY IS KEY Written by Mike Butler, CEO, Symprove

Therapeutic use of probiotics isn’t new. The use of fermented foods to improve intestinal health has been recorded back thousands of years, a long time before there was an ounce of understanding of the gut microbiome and the importance of its managment.1

faecal transplantation, predicted the existence of bacterial translocation from the intestinal lumen into the bloodstream and lymphatic system and theories linking chronic inflammation with atherosclerosis.2 As our knowledge of the gut microbiome has grown, so has our

The Russian scientist Eli Metchnikoff (generally believed to be the

scepticism of probiotics. Some of this scepticism is fair, some

‘father of probiotics’) first hypothesised that lactic acid bacteria

not so, as we bucket a group of probiotics which come in various

provided either a type of protection from, or reversal of, intestinal

different shapes and sizes and treat them as equal. This is just

auto-intoxication. He won the Nobel Prize in medicine in 1908 by

not the case as there are various formulations, bacterial strains,

demonstrating harmful microbes can be replaced by beneficial

mode of delivery and impact on microbiota to consider.3 So what

microbes to treat intestinal illnesses. His regimen became sour

do we need to do to change perceptions and show the value of

milk in the hope of populating his digestive tract with Bulgarian

probiotics?

bacillus (Lactobacillus bulgaricus) – the first use of ‘probiotics’ as a dietary supplement. Mehcnikoff laid the foundations for

Firstly, we need to be brave like Mehcnikoff and explore the

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FEATURE possibilities of human health beyond our existing beliefs. Our gut microbiota contains tens of trillions of micro-organisms, including at least 1,000 different species of known bacteria with more than 3 million genes (150 times more than human genes). To put it in perspective, the Human Genome Project took 15 years to complete

LUTATHERA® ▼ LUTETIUM (177Lu) OXODOTREOTIDE

so we inevitably have far more to understand about the makeup of the gut microbiome. However, already we are seeing positive results for some probiotics in improving people’s health. It will take time to know the exact potential of probiotics work and also our understanding of the gut microbiome, its full role and where it can be adapted to improve lives, but we are working with safe food supplements which allow us to be braver with their application. Secondly, the balance between science driven and commercial goals needs to be heavily weighted towards the former. As on market penetration and not mode of action. However, if we are going to realise the potential of probiotics, an evidence based, long-term approach needs to be undertaken for all manufacturers of probiotics. By following the science, there is a real possibility that we might find something that is ‘game-changing’. This is already a growing appetite to push our current perceptions, understanding and application of probiotics. For example, trials are now looking at the link between the microbiome Parkinson’s and the gut brain-axis.4 As we continue to learn about the different ‘good’ bacteria, the way they arrive in the gut in an alive state, survive hostile gastric conditions and thrive in the colon, we will get a better understanding of this complex microsystem that is living inside all of us. Ten years from now, I am confident that we will be looking back at today as the cusp of a revolution, one in which the science-led probiotics will have an important part to play. References: 1. Ozen M and Dinleyici EC. The history of probiotics: the untold

2. Mackowiak PA. Recycling Metchnikoff: Probiotics, the Intestinal Microbiome and the Quest for Long Life. Front Public Health. 2013; 1: 52. 3. Gaisford S. et al. Comparative survival of commercial probiotic formulations: Tests in biorelevant gastric fluids and real-time measurements using microcalorimetry. Beneficial Microbes 6(1): 1-11 · October 2014 4. Chaudhuri R. Kings Colledge London. Oral Symprove (a probiotic) for the management of motor and non-motor symptoms in people with Parkinson’s: a novel randomised,

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Advanced Accelerator Applications at: pharmacovigilance@adacap.com pv@imagingequipment.co.uk Tel: 33 (0) 785 61 90 66, Switchboard +334 50 99 30 70, Fax +334 50 99 30 71 Prescribing Information; Lutathera 370 MBq/mL solution for infusion. Lutetium (177Lu) oxodotreotide Presentation: Solution for infusion. Clear, colourless to slightly yellow solution. One mL of solution contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration. The total amount of radioactivity per single dose vial is 7,400 MBq at the date and time of infusion. Uses: Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults. Administration: Lutathera should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings and after evaluation of the patient by a qualified physician. Before starting treatment with Lutathera, somatostatin receptor imaging (scintigraphy or positron emission tomography [PET]) must confirm the overexpression of these receptors in the tumour tissue with the tumour uptake at least as high as normal liver uptake (tumour uptake score ≥ 2). Additionally before each administration and during the treatment, tests are required to re assess the patient’s condition and adapt the therapeutic protocol if necessary (dose, infusion interval, number of infusions). See SmPC for further details. The recommended treatment regimen of Lutathera in adults consists of 4 infusions of 7,400 MBq each. The recommended interval between each administration is 8 weeks which could be extended up to 16 weeks in case of dose modifying toxicity (DMT). For renal protection purpose, an amino acid solution must be administered intravenously. See SmPC for further details. Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution is adjusted between 20.5 mL and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion. Lutathera must be administered by slow intravenous infusion over approximately 30 minutes, concomitantly with amino acid solution administered by contralateral intravenous infusion (separate intravenous catheter and initiated 30 minutes prior to Lutathera). This medicinal product must not be injected as a bolus. Premedication with antiemetics should be injected 30 minutes before the start of amino acid solution infusion. The recommended infusion method for administration of Lutathera is the gravity method. During the administration the recommended precaution measures should be undertaken. Lutathera should be infused directly from its original container. The vial must not be opened or the solution transferred to another container. During the administration only disposable materials should be used. The medicinal product should be infused through an intravenous catheter placed in the vein exclusively for its infusion. See SmPC for further details of storage, room and equipment requirements, as well as detailed administration procedure. In some circumstances, it might be necessary to temporarily discontinue treatment with Lutathera, adapt the dose after the first administration or discontinue the treatment. General Warnings: Contraindications include hypersensitivity to the active substance, to any of the excipients, established or suspected pregnancy or when pregnancy has not been excluded, kidney failure with creatinine clearance < 30 mL/min. Special precautions should be taken where patients have renal or urinary tract morphological abnormalities, urinary incontinence, mild to moderate chronic kidney disease with creatinine clearance ≥ 50 mL/min, haematologic toxicity greater or equal to grade 2 (CTCAE) before treatment other than lymphopenia, bone metastasis or have had previous chemotherapy. Late-onset myelodisplastic syndrome (MDS) and acute leukaemia (AL) have been observed after treatment with Lutathera, factors such as age >70 years, impaired renal function, baseline cytopenias, prior number of therapies, prior exposure to chemotherapeutic agents (specifically alkylating agents), and prior radiotherapy are suggested as potential risks and/or predictive factors. Crises due to excessive release of hormones or bioactive substances may occur and overnight hospitalisation should be considered for vulnerable patients. Radioprotection rules should be followed including special care in the event of extravasation and urinary incontinence, see SmPC for full details or radio protective measures. The product contains up to 3.5 mmol sodium and this should be considered in patients on a sodium controlled diet. Undesirable effects: Common side effects include bone marrow toxicity with thrombocytopenia, lymphopenia, anaemia or pancytopenia. Nephrotoxicity with haematuria, renal failure, proteinuria. Blood creatinine increased, nausea, vomiting, fatigue, QT prolonged, hypertension, flushing, hypotension, dyspnoea, abdominal distension, diarrhoea, abdominal pain, constipation, dyspepsia, gastritis, hyperbilirubinaemia, alopecia, musculoskeletal pain, muscle spasms, acute kidney injury, increased LFTs. Marketing Authorisation Holder: Advanced Accelerator Applications 20 rue Diesel 01630 Saint Genis Pouilly France Marketing Authorisation Number EU/1/17/1226/001 Legal Category: POM Price: £17,875 per vial Date of preparation of PI: October 2017 Date of preparation: May 2019

Job ID Number: AAA.Lu177-UKI-0013

GASTROENTEROLOGY TODAY - SUMMER 2019

story. Benef Microbes. 2015;6(2):159-65.

Lutathera® ▼ lutetium (177Lu) oxodotreotide is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults. www.lutathera.com

AAA-Lu177-GL-0028

probiotics are a safe food supplement, it is easy for some to focus

double-blind, placebo-controlled pilot study.

From Norgine, the company that brought you MOVIPREP® (Macrogol 3350, sodium sulphate, ascorbic acid, sodium ascorbate and electrolytes) NEWS The first 1 litre PEG bowel preparation1-3

Improve the efficacy cut the volume vs MOVIPREP®1 PLENVU® PM/AM dosing was superior to MOVIPREP® in the per protocol population (successful overall cleansing 97.3% vs 92.2%, p=0.014) Safety profile comparable to MOVIPREP®1,4-6

Powder for Oral Solution PEG 3350, Sodium Ascorbate, Sodium Sulfate, Ascorbic Acid, Sodium Chloride, and Potassium Chloride

UK AND IE PRESCRIBING INFORMATION: Plenvu powder for oral solution (Macrogol 3350 + Sodium ascorbate + Ascorbic acid + Sodium sulfate anhydrous + Potassium chloride + Sodium chloride) Please refer to the full Summary of Product Characteristics (SmPC) before prescribing. Presentation: Plenvu powder for oral solution is administered in two doses. Dose one is made up of 1 sachet containing: macrogol 3350 100g, sodium sulfate anhydrous 9g, sodium chloride 2g, potassium chloride 1g. Dose 2 is made up of 2 sachets (A and B). Sachet A contains: macrogol 3350 40g, sodium chloride 3.2g, potassium chloride 1.2g. Sachet B contains: sodium ascorbate 48.11g, ascorbic acid 7.54g. Indication: For bowel cleansing in adults, prior to any procedure requiring a clean bowel.

GASTROENTEROLOGY TODAY - SUMMER 2019

Dosage and administration: For oral use. Adults and elderly: A course of treatment consists of two separate non-identical 500ml doses of Plenvu. At least 500ml of additional clear fluid must be taken with each dose. Treatment can be taken according to a two-day or one-day dosing schedule. Two-day dosing schedule: First dose taken the evening before the procedure. Second dose in the early morning of the day of the procedure. Morning only dosing schedule: Both doses taken the morning of the procedure. The two doses should be separated by a minimum of 1 hour. Day before dosing schedule: Both doses taken the evening before the procedure. The two doses should be separated by a minimum of 1 hour. No solid food should be taken from the start of the course of treatment until after the clinical procedure. Consumption of all fluids should be stopped at least 2 hours prior to a procedure under general anaesthesia or 1 hour prior to a procedure without general anaesthesia. Children: Not recommended for use in children below 18 years of age. Patients with renal or hepatic impairment: No special dosage adjustment is deemed necessary in patients with mild to moderate renal or hepatic impairment. Patients should be advised to allow adequate time after bowel movements have subsided to travel to the clinical unit. Contraindications: Hypersensitivity to the active substances or to any of the excipients, gastrointestinal obstruction or perforation, ileus, disorders of gastric emptying (gastroparesis, gastric retention), phenylketonuria, glucose-6-phosphate dehydrogenase deficiency, toxic megacolon. Warnings and precautions: The fluid content of reconstituted Plenvu does not replace regular fluid intake. Adequate fluid intake must be maintained. As with other macrogol containing products, allergic reactions including rash, urticaria, pruritus, angioedema and anaphylaxis are a possibility. Caution should be used with administration to frail or debilitated patients, in patients with impaired gag reflex, with the possibility of regurgitation or aspiration, or with diminished levels of consciousness, severe renal impairment, cardiac failure (grade III or IV of NYHA), those at risk of arrhythmia, dehydration or severe acute inflammatory bowel disease.

In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte, renal function test and ECG as appropriate. Any suspected dehydration should be corrected for before use of Plenvu. There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparation, predominantly in patients with underlying cardiac risk factors and electrolyte disturbance. If patients develop any symptoms indicating arrhythmia or shifts of fluid/electrolytes during or after treatment, plasma electrolytes should be measured, ECG monitored and any abnormality treated appropriately. If patients experience severe bloating, abdominal distension, or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms subside. The sodium content, 458.5mmol (10.5g), should be taken into consideration for patients on a controlled sodium diet. The potassium content, 29.4mmol (1.1g), should be taken into consideration by patients with reduced kidney function or those on a controlled potassium diet. Interactions: Medicinal products taken orally within one hour of starting colonic lavage with Plenvu may be flushed from the gastrointestinal tract unabsorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected. Fertility, pregnancy and lactation: There are no data on the effects of Plenvu on fertility in humans. There were no effects on fertility in studies in male and female rats. It is preferable to avoid the use of Plenvu during pregnancy. It is unknown whether Plenvu active ingredients/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to abstain from Plenvu therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Effects on ability to drive and use machines: Plenvu has no influence on the ability to drive and use machines. Undesirable effects: Diarrhoea is an expected outcome. Common: vomiting, nausea, dehydration. Uncommon: abdominal distension, anorectal discomfort, abdominal pain, drug hypersensitivity, headache, migraine, somnolence, thirst, fatigue, asthenia, chills, pains, aches, palpitation, sinus tachycardia, transient increase in blood pressure, hot flush, transient increase in liver enzymes, hypernatraemia, hypercalcaemia, hypophosphataemia, hypokalaemia, decreased bicarbonate, anion gap increased/ decreased, hyperosmolar state.

UNITED KINGDOM: Price and pack sizes: £12.43 (3 sachet) Legal category: Pharmacy medicine MA Number: PL 20011/0040 MA Holder: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK IRELAND Legal category: Product subject to medical prescription which may be renewed MA Number: PA 1336/005/001 MA Holder: Norgine BV, Hogehilweg 7, 1101CA Amsterdam ZO, The Netherlands Additional information is available on request or in the SmPC. For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex, United Kingdom UB9 6NS. Telephone: +44(0)1895 826606. Email: medinfo@norgine.com Date of preparation: March 2019 Company reference: UK/PLV/0319/0147

United Kingdom Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Norgine Pharmaceuticals Ltd on: Tel: +44 (0)1895 826 606 Email: medinfo@norgine.com Ireland Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Adverse events should also be reported to Norgine Pharmaceuticals Ltd on: Tel: +44 (0)1895 826 606 Email: medinfo@norgine.com

Refer to the SmPC for a full list and frequency of adverse events.

References: 1. Bisschops R, et al. Endoscopy 2018; doi: 10.1055/a-0638-8125. 2. Schreiber S, et al. Endoscopy 2018; doi: 10.1055/a-0639-5070. 3. DeMicco MP, et al. Gastrointest Endosc 2018; doi: 10.1016/j.gie.2017.07.047. 4. PLENVU® UK Summary of Product Characteristics. October 2018. 5. MOVIPREP® UK Summary of Product Characteristics. September 2018. 6. MOVIPREP® Orange UK Summary of Product Characteristics. August 2017. UK/PLV/0519/0164 Date of preparation: May 2019

Moviprep and Moviprep Orange (Macrogol 3350, sodium sulphate, ascorbic acid, sodium ascorbate and electrolytes) Prescribing Information REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING Presentation: A box containing two transparent bags, each containing two separate sachets, A and B. Sachet A contains macrogol 3350 100g; sodium sulphate anhydrous 7.5g; sodium chloride 2.691g and potassium chloride 1.015g as white to yellow powder. Sachet B contains ascorbic acid 4.7g and sodium ascorbate 5.9g as white to light brown powder. Moviprep also contains aspartame (E951), acesulfame potassium (E950) and a lemon or orange flavour. Uses: Bowel cleansing prior to any clinical procedure requiring a clean bowel. Dosage and administration: Adults and Older People: A course of treatment consists of two litres of Moviprep. A litre of Moviprep consists of one Sachet A and one Sachet B dissolved together in water to make one litre. This one litre reconstituted solution should be drunk over a period of one to two hours. This process should be repeated with a second litre of Moviprep to complete the course. A further litre of clear fluid is recommended during the course of treatment. This course of treatment can be taken either as divided or as single doses and timing is dependent on whether the clinical procedure is conducted with or without general anaesthesia as specified below: For procedures conducted under general anaesthesia: 1. Divided doses: one litre of Moviprep in the evening before and one litre of Moviprep in the early morning of the day of the clinical procedure. Ensure consumption of Moviprep as well as any other clear fluids has finished at least two hours before the start of the clinical procedure. 2. Single dose: two litres of Moviprep in the evening before the clinical procedure or two litres of Moviprep in the morning of the clinical procedure. Ensure consumption of Moviprep as well as any other clear fluids has finished at least two hours before the start of the clinical procedure. For procedures conducted without general anaesthesia: 1. Divided doses: one litre of Moviprep in the evening before and one litre of Moviprep in the early morning of the day of the clinical procedure. Ensure consumption of Moviprep as well as any other clear fluids has finished at least one hour before the start of the clinical procedure. 2. Single dose: two litres of Moviprep in the evening before the clinical procedure or two litres of Moviprep in the morning of the clinical procedure. Ensure consumption of Moviprep has finished at least two hours before the start of the clinical procedure. Ensure consumption of any clear fluids has finished at least one hour before the clinical procedure. Patients should be advised to allow for appropriate time to travel to the colonoscopy unit. No solid food should be taken from the start of the course of treatment until after the clinical procedure. Children: Not recommended in children below 18 years of age. Contra-indications, warnings etc: Contra-indications: Known or suspected hypersensitivity to any of the ingredients, gastrointestinal obstruction or perforation, disorders of gastric emptying, ileus, phenylketonuria, glucose-6-phosphate dehydrogenase deficiency, toxic megacolon which complicates very severe inflammatory conditions of the intestinal tract. Do not use in unconscious patients. Warnings: Diarrhoea is an expected effect. Administer with caution to fragile patients in poor health or patients with serious clinical impairment such as impaired gag reflex, or with a tendency to aspiration or regurgitation, impaired consciousness, severe renal insufficiency, cardiac impairment (NYHA grade III or IV), those at risk of arrhythmia, dehydration, severe acute inflammatory bowel disease. Dehydration, if present, should be corrected before using Moviprep. The reconstituted Moviprep does not replace regular fluid intake and adequate fluid intake must be maintained. Semi-conscious patients or patients prone to aspiration should be closely monitored during administration, particularly if this is via a naso-gastric route. If symptoms indicating arrhythmia or shifts of fluid or electrolytes occur, plasma electrolytes should be measured, ECG performed and any abnormality treated appropriately. In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician should consider performing baseline and post-treatment electrolyte, renal function test and ECG as appropriate. The possibility of serious arrhythmias, predominantly in those with underlying cardiac risk factors and electrolyte disturbance cannot be ruled out. If patients experience symptoms which make it difficult to continue the preparation, they may slow down or temporarily stop consuming the solution and should consult their doctor. Moviprep containing orange flavour is not recommended for patients with glucose and galactose malabsorption. Moviprep contains 56.2 mmol of absorbable sodium per litre (caution in patients on a controlled sodium diet), 14.2 mmol potassium per litre (caution in patients with reduced kidney function or patients on a controlled potassium diet). Interactions: Oral medication should not be taken within one hour of administration as it may be flushed from the GI tract and not absorbed. Pregnancy and lactation: There is no experience of use in pregnancy or lactation so it should only be used if judged essential by the physician. Side Effects: Very common or common: abdominal pain, nausea, abdominal distension, anal discomfort, malaise, pyrexia, vomiting, dyspepsia, hunger, thirst, sleep disorder, headache, dizziness, and rigors. Uncommon or unknown: Dysphagia, discomfort, abnormal liver function tests, allergic reactions including rash, urticaria, pruritus, erythema, angioedema and anaphylaxis, dyspnoea, electrolyte disturbances, dehydration, convulsions associated with severe hyponatraemia, transient increase in blood pressure, arrhythmia, palpitations, flatulence and retching. Refer to the Summary of Product Characteristics (SmPC) for full list and frequency of adverse events. Overdose: In case of gross accidental overdosage, conservative measures are usually sufficient. In the rare event of severe metabolic derangement, intravenous rehydration may be used. Pharmaceutical Particulars: Sachets: Store in the original package below 25°C. Reconstituted solution: Keep covered. May be stored for up to 24 hours below 25°C or in a refrigerator. Legal Category: UK – Pharmacy only, Ireland - Prescription medicine. Packs: One pack of Moviprep or Moviprep Orange contains a single treatment. Basic NHS Price: UK £10.36, Ireland €13.26 Marketing Authorisation Number: UK: PL 20142/0005 (Moviprep), PL 20011/0006 (Moviprep Orange). IE: PA 1336/1/1(Moviprep), PA 1336/1/2 (Moviprep Orange). For further information contact: Norgine Pharmaceuticals Ltd, Moorhall Road, Harefield, Middlesex UB9 6NS Tel: +44 (0) 1895 826606 E-mail: medinfo@norgine.com Date of preparation/revision: March 2018. Ref UK/MPR/0318/0182

PLENVU, MOVIPREP, NORGINE and the sail logo are registered trademarks of the Norgine group of companies.

ENVU UK IRE GASTRO TODAY JUNE AD 210x297_FINAL.indd 23/05/2019 11:11 2

Raising the bar for IBD care - launch of 2019 IBD Standards By Rukshana Kapasi, Chair of IBD UK The 2019 BSG conference sees the launch of the revised UK-wide IBD Standards, new exciting guidelines which could lead to drastic changes in how we care for people

be organised to deliver this. The Standards complement the recently published BSG and ACPGBI IBD guidelines. All IBD Services should be working towards delivering the IBD Standards and the IBD UK website will house guidance and resources to help services implement these. Also being launched is a benchmarking tool which will allow the IBD Service to compare its performance against the standards, as well as

with Crohn’s or Colitis.

with other services.

These build on the previous IBD Standards

It is important to note that benchmarking is an

(published in 2009 and updated in 2013) and have been devised by IBD UK, a partnership of 17 patient and professional organisations, including the British Society of Gastroenterology, Royal College of Nursing, Crohn’s & Colitis UK, CIRCA and Ileostomy Association, who are working together for everyone affected by Inflammatory Bowel

extremely positive tool for IBD Services – as well as highlighting the things they are doing brilliantly at; it can be an opportunity to push through some real changes. It is designed to help with putting together business cases based on empirical evidence, to make the best use of resources and establish priorities.

Disease.

From the launch date in June to August, one

The first audit of IBD Services in 2006

the team) can register to sign up the

highlighted wide variation in the quality and

person from the IBD Service (representing benchmarking tool on the IBD UK website. The

consistency of care for people with Crohn’s

period of September to December is when the

and Colitis, and whilst significant improvements

tool will need to be filled out. This will involve

have been made, this is unfortunately still the

answering questions that align with the IBD

case. Not only this, the way we care for people

Standards statements.

with Crohn’s and Colitis has changed in the intervening years, with new therapy options, and

Alongside this, IBD UK, supported by Crohn’s

a shift to self-management and personalised

& Colitis UK, will be launching the first UK-wide

care and support.

IBD patient survey to ensure that the patient perspective is central, and that the patient

This version of the standards has seen a

experience helps shape the IBD service.

transformation, putting the patient at the centre

People with Crohn’s and Colitis will be able to

and ensuring that everything we are asking for

anonymously feedback on the Service.

will ultimately make a difference to people with the conditions.

The benchmarking tool together with the patient survey are valuable tools that will

When revising the standards, it was also

enable IBD Services to be more effective

important for us to consider technological

with their team and efficient with resources

advances, which have led to a huge change

and finances. This is an exciting and ground

in the way we treat patients. Alongside this,

breaking opportunity for services and patients

society now takes a more holistic view towards

to work collaboratively leading to the shared

care, not just for people with Crohn’s and

priority of improving the lives of people with

Colitis, but across condition areas.

Crohn’s and Colitis.

The 2019 IBD Standards are a framework

The Standards have been produced by

of statements that define what should be

patients and professionals working together

put in place to deliver safe, high-quality,

and it is fundamental that this partnership

personalised care for people with Crohn’s and

approach continues to make them a reality.

Colitis. They cover all stages of the patient

We need everybody to get involved to

journey: pre-diagnosis, newly diagnosed,

make a difference. To find out more about

flare management, surgery, inpatient care and

the IBD Standards and to register for the

ongoing care, and how the IBD service should

benchmarking tool visit ibduk.org.uk

GASTROENTEROLOGY TODAY - SUMMER 2019

United Kingdom Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826606. Ireland Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Norgine Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals on +44 1895 826606 or E-mail: medinfo@norgine.com

NEWS

ARE YOU DOING YOUR BEST FOR PBC PATIENTS? Inadequate or intolerant response to UDCA is defined as ALP >1.67 x ULN (>200 IU/L) and/or bilirubin 2 x ULN1 1

PBC expertise is closer than you think...

2 3

8 14

4 25

Consider referral to 1 of 26 PBC hubs in the UK comprised of specialist multidisciplinary teams for individualised patient treatment and second line therapy.

6 11 7 23

Find your nearest PBC referral hub at www.uk-pbc.com/ newtherapiesinpbc/

10 18 5

Liver Centres 1.

Aberdeen Royal Infirmary

3. Glasgow Royal Infirmary 4. Edinburgh Royal Infirmary 5. University Hospital Wales, Cardiff 6. Royal Victoria Hospital, Belfast 7.

Aintree Univ Hosp NHS FT

8. Barts Health NHS Trust

9. Bradford Teaching 10. Cambridge Univ Hosp NHS FT 11. East Lancashire Hosps NHS Trust 12. Hull & East Yorkshire NHS Trust 13. King’s College Hosp NHS FT 14. Imperial College Healthcare Trust

22 27 19

PBC Hubs

2. Ninewells Hospital, Dundee

15. Leeds Teaching Hosp NHS Trust 16. Manchester University NHS FT 17. Nottingham Univ Hosp NHS Trust 18. Oxford Univ Hosps NHS FT 19. Portsmouth Hosps NHS Trust 20. Royal Devon & Exeter FT

21. Royal Free London NHS FT 22. Royal Surrey County Hosp NHS FT 23. Royal L’pool/Broadgreen Univ Trust 24. Sheffield Teaching Hosp FT 25. St George’s Univ Hosps NHS FT 26. The Newcastle upon Tyne Hosps FT

27. Univ Hosp Southampton NHS FT 28. Univ Hosps Birmingham NHS FT 29. Univ Hosps Leicester NHS Trust 30. Univ Hosps Plymouth NHS Trust 31. University Hosp Bristol NHS FT 32. York Teaching Hospital NHS FT

Find out more information in the BSG guidelines at www.bsg.org.uk/clinical/bsg-guidelines.html Abbreviated Prescribing Information OCALIVA® (obeticholic acid) (Please refer to the Full Summary of Product Characteristics (SmPC) before prescribing)

GASTROENTEROLOGY TODAY - SUMMER 2019

Presentation: OCALIVA supplied as film-coated tablets containing 5 mg and 10 mg obeticholic acid. Indication: For the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Dosage and administration: Oral administration. Hepatic status must be known before initiating treatment. In patients with normal or mildly impaired (Child Pugh Class A) hepatic function, the starting dose is 5 mg once daily. Based on an assessment of tolerability after 6 months, the dose should be increased to 10 mg once daily if adequate reduction of alkaline phosphatase (ALP) and/or total bilirubin have not been achieved. No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid. For cases of severe pruritus, dose management includes reduction, temporal interruption or discontinuation for persistent intolerable pruritus; use of bile acid binding agents or antihistamines (see SmPC). Moderate to Severe Hepatic Impairment: In patients with Child-Pugh B or C hepatic impairment, a reduced starting dose of 5mg once weekly is required. After 3 months, depending on response and tolerability, the starting dose may be titrated to 5 mg twice weekly and subsequently to 10 mg twice weekly (at least 3 days between doses) if adequate reductions in ALP and/or total bilirubin have not been achieved. No dose adjustment required in Child Pugh Class A function. Mild or moderate renal impairment: No dose adjustments are required. Paediatric population: No data. Elderly: No dose adjustment required;

limited data exists. Contraindications: Hypersensitivity to the active substance or any excipients. Complete biliary obstruction. Special warnings and precautions for use: After initiation, patients should be monitored for progression of PBC with frequent clinical and laboratory assessment of those at increased risk of hepatic decompensation. Dose frequency should be reduced in patients who progress from Child Pugh A to Child Pugh B or C Class disease. Serious liver injury and death have been reported in patients with moderate/severe impairment who did not receive appropriate dose reduction. Liver-related adverse events have been observed within the first month of treatment and have included elevations in alanine amino transferase (ALT), aspartate aminotransferase (AST) and hepatic decompensation. Interactions: Following coadministration of warfarin and obeticholic acid, International Normalised Ratio (INR) should be monitored and the dose of warfarin adjusted, if needed, to maintain the target INR range. Therapeutic monitoring of CYP1A2 substrates with narrow therapeutic index (e.g. theophylline and tizanidine) is recommended. Obeticholic acid should be taken at least 4-6 hours before or after taking a bile acid binding resin, or at as great an interval as possible. Fertility, pregnancy and lactation: Avoid use in pregnancy. Either discontinue breast-feeding or discontinue/abstain from obeticholic acid therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. No clinical data on fertility effects. Undesirable effects: Very common (≥1/10) adverse reactions were pruritus, fatigue, and abdominal pain and discomfort. The

ALP, alkaline phosphatase; PBC, primary biliary cholangitis, UDCA, ursodeoxycholic acid; ULN, upper limit of normal.

18 1.

EASL guidelines. J Hepatol. 2017;67:145–172

UK-PP-PB-0376 May 2019

most common adverse reaction leading to discontinuation was pruritus. The majority of pruritus occurred within the first month of treatment and tended to resolve over time with continued dosing. Other commonly (≥ 1/100 to < 1/10) reported adverse reactions are, thyroid function abnormality, dizziness, palpitations, oropharyngeal pain, constipation, eczema, rash, arthralgia, peripheral oedema, and pyrexia. Please refer to the SmPC for a full list of undesirable effects. Overdose: Liver-related adverse reactions were reported with higher than recommended doses of obeticholic acid. Patients should be carefully observed, and supportive care administered, as appropriate. Legal category: POM Marketing authorisation numbers: EU/1/16/1139/001 & 002 Marketing authorisation holder: Intercept Pharma Ltd, 2 Pancras Square, London, N1C 4AG, United Kingdom Package Quantities and Basic NHS cost: OCALIVA 5 mg and 10 mg £2,384.04 per bottle of 30 tablets. Date of revision: 11th April 2018

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Intercept Pharma Ltd on +44 (0)330 100 3694 or email: drugsafety@interceptpharma.com

NEWS How can sites participate? We are starting our monitoring of biosimilars with Hyrimoz (adalimumab), with Zessly (infliximab) coming soon.

New biosimilar safety monitoring initiative in IBD The introduction of biological treatments has made a significant difference in the lives of many IBD patients. The advent of multiple biosimilars (generic medicines that are biologically similar to the originator)

If your IBD service is using one of these biosimilars, please get in touch with us if you would like to participate in these important studies. The wider the data collection, the more closely it reflects real-world effects,

so we encourage you to join with us to gather the evidence. We will be initiating a number of similar studies shortly. For further information or to get involved please contact the IBD Registry email: support@ibdregistry.org.uk Tel 020 3393 3969

increases the affordability and so availability of these life-changing treatments. A primary aim of the IBD Registry is to help improve the quality of life for people with IBD, by using our UK-wide reach to collect and analyse relevant data. With over 54,000 patient records, the UK IBD Registry is one of the largest IBD registries in Europe. The recent introduction of biosimilar medicines has placed the Registry in a key position to facilitate the collection of crucial, on-going safety data as these treatments become more widely used. We are pleased to announce that the Registry will soon be facilitating a series of observational post market authorisation safety studies using our existing web-based data collection systems. Our first study will monitor the use of Hyrimoz, an adalimumab biosimilar, produced by Sandoz. The study is part of routine clinical care, but patients will be asked to consent to their data being used in the study.

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NEWS National charity Coeliac UK and Innovate UK announce £750k boost to research that unlocks gluten free challenges Coeliac UK, the national charity for people who need to live gluten free, has combined forces with Innovate UK, the UK’s innovation agency, to drive improvements worth £750,000 in the food technology, diagnostics and digital care industries.

Sarah Sleet, chief executive of Coeliac UK said: “Coeliac UK is a world leader on coeliac disease, supporting research that makes a real world impact. This new research to create a different diagnostic test could help unlock a worldwide problem for millions of people without a proper diagnosis of coeliac disease, while the research on innovative gluten free ingredients will keep the UK ahead in the food industry’s expansion into gluten free. Meanwhile our third funded project could offer real savings to the NHS in the management of the lifelong autoimmune condition that is coeliac disease providing a service model for the many other chronic long term conditions in the UK.”

The funding will support projects based in Birmingham, Newcastle and Edinburgh and is part of Innovate UK’s partnership with the third sector on health research projects, bringing direct benefits to both patients and UK businesses. The UK has been at the forefront of the most dynamic growth area in free from food retailing and Coeliac UK is the world’s largest support organisation for people with coeliac disease. This collaboration will build on these strengths by

Dr Kath Mackay, Director of Ageing Society, Health and Nutrition at Innovate UK, said: “Stimulating innovation in our food and health sectors are crucial components of the government’s industrial strategy. By working with Coeliac UK we will be able to offer funding that results in improved quality of life for people with this condition and support and stimulate our vibrant health care and food technology sectors.”

supporting research advances in food technology, GastroToday_Jan_2019_v4 26/01/2019 09:39 Page 1 The three projects reflect the key challenges diagnostic techniques and digital care. of living with coeliac disease and a gluten free life: New test to provide a less invasive way of diagnosing coeliac disease - Nonacus Ltd, Birmingham

GASTROENTEROLOGY TODAY - SUMMER 2019

The average time to gain a coeliac disease diagnosis is 13 years and there are half a million people in the UK undiagnosed – and in the tens of millions worldwide. Nonacus Ltd, working with researchers at the University of Cambridge led by Dr Elizabeth Soilleux, will together develop a test for coeliac disease. Current tests only work if

new test will rely on a proprietary laboratory test in conjunction with a patented computer algorithm. It’s a completely new way of looking at the immune cells and can identify patients with coeliac disease by predicting how likely immune cells are to be responding to gluten. It aims to develop a coeliac disease test for people who have already adopted a gluten free diet, as well as an improvement on the current method of analysing biopsy samples. This will not only save considerable patient suffering but will also provide savings to the NHS speeding up diagnosis journeys. Development of three new plant proteins to help improve the ingredients used in gluten free bread - Nandi Proteins Ltd, Scotland To improve gluten free bread by developing revolutionary new ingredients. Nandi Proteins Ltd (a protein technology company), Genius Foods (gluten free food manufacturer) AB Mauri (distributor of bakery ingredients) and Agrii (a plant science and technology company) will join researchers at Heriot Watt University to develop three kinds of new plant proteins. The proteins will be derived from crops which are underused in the UK: rapeseed cake, faba beans and naked oats. These new ingredients could replace the expensive egg and dairy based ingredients currently used, improve the nutrient profile, taste and texture of gluten free bread and reduce the need for E number additives. Development of these new ingredients will also open up new markets for UK grown crops and add value to the UK economy. Overall consumers could see cheaper and better quality gluten free products. Software innovation to help in the ongoing management of coeliac disease - Cievert Ltd, Newcastle Software will be developed to better manage coeliac disease. Working with leading researchers from Sheffield University, the goal is to find patients with coeliac disease that need more support, compared to those who are living well. The software, when developed, will let people receive the assurance of being clinically followed up without the inconvenience, time and cost of hospital appointments. Whilst those who need additional care will be identified quickly and easily so that they can access crucial support when they need it most. This could be technology that is applied to other conditions

patients are still

in the future resulting in substantial savings for

eating gluten. The

the NHS.

ith

IMPROVING QUALITY INNEWS DIAGNOSTIC ENDOSCOPY WITH 18 WEEK SUPPORT Standards in colonoscopy have improved greatly over the last decade although there is still variability in the adenoma detection rates (ADR) and cancer miss rates across the UK. The bowel cancer screening program has also helped to improve standards with the introduction of competency assessment. Upper GI endoscopy however has fallen behind and cancer miss rates in the upper gastrointestinal tract remain far too high reaching between 10% and over 20%.

provides support to both Endoscopists and

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Raising the standard of care Our clinical teams are committed to working

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had excellent feedback from delegates. Furthermore, there is evolving evidence that training bundles are effective in improving ADR, in particular the use of position change, cleansing agents, muscular relaxants and extended withdrawal. There are other techniques which improve polyp detection including the Endocuff Vision and water exchange colonoscopy. At 18 Weeks our nurses independently measure withdrawal times and routinely polyp spot to try and improve the ADR. The technical aspects of upper GI endoscopy that are likely to improve the detection and

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Raising the standard of care Our clinical teams are committed to Criteria & Quality working weekends to provide a wide range We select Endoscopists with an endoscopy of clinical services. Many of our clinical leads orientated career path and performance are experts in their field. So not only do measures above the national average. JAG patients benefit from the work our teams do, audit data is constantly monitored to ensure there is also an opportunity for NHS Trust ongoing quality. Furthermore, we have a teams to improve efficiencies through new clinical governance department that is crucial techniques or approaches.

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NEWS policy, research and campaigns said: “It is

gluten ataxia and neuropathy, and although

Is your IBS actually undiagnosed coeliac disease?

essential that awareness of the similarity of the

rare, there is an increased risk of small bowel

symptoms increases and that GPs adhere to

cancer and intestinal lymphoma.

• 97%¹ of people don’t realise IBS symptoms could be coeliac disease • 1 in 4 people with coeliac disease were previously misdiagnosed with IBS • Half a million people in the UK are living with coeliac disease without knowing it With only 3%1 of British adults aware that the symptoms of IBS (irritable bowel syndrome)

the NICE (National Institute for Health and Care Excellence) guideline which states that anyone

“The first step to diagnosing coeliac disease is

with IBS symptoms should be tested for coeliac

a simple, inexpensive blood test done in primary

disease before a diagnosis of IBS is made.”

care, but thousands of people are not getting the necessary testing and are being left undiagnosed

Coeliac disease is not an allergy or an

including those with IBS symptoms. This not

intolerance but an autoimmune disease where

only causes years of unnecessary suffering but

the body’s immune system damages the lining

also wasted costs to the NHS with repeated

of the small bowel when gluten, a protein

appointments and investigations.

(found in wheat, barley and rye) is eaten. There is no cure and no medication; the only

We urge anyone who has symptoms such as

treatment is a strict gluten free diet for life.

ongoing bloating, diarrhoea or constipation and has been given a diagnosis of IBS but not

are also common symptoms of coeliac disease, national charity Coeliac UK, is

1 in 100 people in the UK is estimated to

been tested for coeliac disease to ask their GP

calling on greater awareness of the similarity

have coeliac disease but of these, only 30%

to test them for coeliac disease. However, it is

of symptoms and urges anyone with IBS to

are currently diagnosed, meaning there are

essential to keep eating gluten until all tests are

ask their GP for a coeliac disease blood test,

nearly half a million people in the UK with

completed as otherwise these tests may give a

if they have not already had one.

undiagnosed coeliac disease.

false negative result,” continued Ms McGough.

As many as 1 in 4 people with coeliac disease

The average time it takes for someone to

Coeliac UK’s online assessment www.coeliac.

were previously misdiagnosed with IBS

get a diagnosis is 13 years from the onset of

org.uk/isitcoeliacdisease, based on the NICE

as many of the symptoms for IBS such as

symptoms; by which time, they may already be

guideline NG20, gives people greater confidence

bloating, stomach pains or cramps, diarrhoea

suffering with added complications caused by

to seek further medical advice from their GP.

or constipation and feeling exhausted are the

the disease. If left untreated, coeliac disease

Upon completion of the assessment, the

same as the symptoms of coeliac disease.

can lead to a number of serious complications,

respondent will receive an email with their results,

including: anaemia, osteoporosis, unexplained

which will indicate whether their symptoms are

infertility, neurological conditions such as

potentially linked to coeliac disease.

Norma McGough Coeliac UK director of

WHY NOT WRITE FOR US? GASTROENTEROLOGY TODAY - SUMMER 2019

Gastroenterology Today welcomes the submission of clinical papers and case reports or news that you feel will be of interest to your colleagues.

Material submitted will be seen by those working within all UK gastroenterology departments and endoscopy units. All submissions should be forwarded to info@mediapublishingcompany.com

If you have any queries please contact the publisher Terry Gardner via: info@mediapublishingcompany.com 1

eference YouGov Survey R When answering the question: ‘What do you think are common symptoms of coeliac disease?’, only 3% of respondents answered IBS symptoms. All figures, unless otherwise stated, are from YouGov Plc. Total sample size was 8423 adults. Fieldwork was undertaken between 20th December 2018 - 2nd January 2019. The survey was carried out online. The figures have been weighted and are representative of all GB adults (aged 18+).

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NEWS Half of patients with deadliest common cancer have unmet support needs, first ever UK survey reveals Physical and psychological support need of patients with the deadliest common cancer are not being met according to the first ever UK survey into the experiences of people with pancreatic cancer. Commissioned by leading charity Pancreatic Cancer UK, the survey revealed that half of all respondents (49 per cent) had one or more unmet support needs considered either high or moderate in severity. The findings show a clear gap in the supportive care being offered to pancreatic cancer patients – a group which the charity believes has been neglected for decades. The survey, conducted by Oxford Brookes University and The Picker Institute on behalf of the charity, recorded the care experiences and support needs of 274 people with pancreatic cancer. The majority (87 per cent) reported one or more support needs, ranging from depression, fatigue, and financial pressures, to changes to appetite. Pancreatic Cancer UK is concerned that a significant proportion of these needs are not being met. It is now calling for the Government and NHS to introduce a holistic needs assessment to ensure that patients have access to personalised care

unaddressed can have a huge detrimental

of diagnosis and particularly for patients

impact on their quality of life. Pancreatic

whose cancer had spread to other organs,

cancer is a complex disease that can

underlining the importance of patients

progress devastatingly quickly, often

receiving specialist psychological care as

leaving those affected with little time with

early as possible.

their loved ones. We want to see support needs assessed for all pancreatic cancer

Currently there are no established

patients immediately after diagnosis so that

psychological interventions for people

they can be helped to maintain as good a

with pancreatic cancer due to a lack

quality of life as possible.

of evidence, and the NICE guidelines on the disease cite this as a key

No one affected by pancreatic cancer should

area for improvement. The charity is

be left to struggle in isolation. Specialist

urging the National Institute for Health

support is available through the Pancreatic

Research (NIHR) to prioritise and invest

Cancer UK Support Line. Our dedicated

research funding for the development of

team of nurses are there to help patients

psychological interventions for people living

and their families but we need fellow health

with and beyond pancreatic cancer.

professionals to signpost them to us.

Most patients were positive about the

The needs of pancreatic cancer patients

care they received, however, the findings

have been neglected for far too long. It’s

indicated key differences between the

imperative that these findings now prompt

experiences of people who were eligible to

further research into the most effective

receive surgery, the only potentially curative

interventions, particularly around mental

treatment for the disease, and those whose

health, so that people with pancreatic cancer

pancreatic cancer was inoperable. People

receive the very best care and support.”

with operable pancreatic cancer were more likely to feel that their diagnosis had

Amy Tallett, Head of Research at Picker,

definitely or to some extent been given in

commented: “Picker is proud to have

a sensitive way (87 per cent), compared to

worked with Pancreatic Cancer UK and

inoperable patients (74 per cent). Similarly,

Oxford Brookes University on this important

37 per cent of people with inoperable

research, and we hope that the findings

pancreatic cancer reported that they had

provide an essential evidence base to

not been given enough information at the

inform continued conversation and actions

point of diagnosis, compared to 27 per cent

to improve care experiences for people

for people with operable disease.

affected by pancreatic cancer. Thank you to everybody that took part in this research.”

immediately after diagnosis.

The extent and breadth of needs and the variations in care experienced by people

Eila Watson, Professor Supportive Cancer

One survey respondent said: “I was not

with pancreatic cancer has previously

Care at Oxford Brookes University,

gone unreported because they are not all

said: “This survey highlights the unmet

captured by the National Cancer Patient

information and support needs that

met but my emotional needs have never

Experience Survey (NCPES). The NCPES

pancreatic cancer patients have across

been addressed. I had no idea where to

is distributed within six to nine months

the cancer trajectory. Needs should be

go for the help I needed and had to search

of diagnosis when many people with

assessed from the point of diagnosis and

online for information.”

pancreatic cancer have already died or are

monitored regularly, with supportive care

too sick to respond. The low number of

interventions implemented to help patients

Patients reported that psychological care

responses mean that pancreatic cancer is

live as good a quality of life as possible.

needs were the most likely to be unmet;

grouped with Upper Gastrointestinal (UGI)

Further research is needed to work out how

almost a third said fears about the future

cancers. The NCPES also does not capture

best to support patients and their families.”

(31 per cent) or fears about the cancer

the experience of those living beyond their

spreading (30 per cent) were not being

diagnosis and treatment.

offered counselling though I really felt I needed it. My physical needs were very well GASTROENTEROLOGY TODAY - SUMMER 2019

suicide is higher in the first six months

Pancreatic Cancer UK operates the only dedicated support line for people affected by

addressed. This is extremely concerning as pancreatic cancer has the lowest survival of

Anna Jewell, Director of Services at

pancreatic cancer staffed by specialist nurses.

all common cancers – less than 7 per cent

Pancreatic Cancer UK, said: “For so

The Pancreatic Cancer UK Support Line is

of people living for 5 years - and the second

many pancreatic cancer patients to tell us

free to call on 0808 801 0707 with support

highest risk of suicide after diagnosis

they have unmet support needs is heart-

available on weekdays 10am-4pm and via

compared to other cancers. This risk of

breaking - these are live needs which if left

email: nurse@pancreaticcancer.org.uk

The only licensed treatment for the reduction in recurrence of overt hepatic encephalopathy (OHE)1

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At home they are still at risk; …TARGAXAN® rifaximin-α reduces the risk of recurrence of overt hepatic encephalopathy.2

Long-term secondary prophylaxis in hepatic encephalopathy (HE)3 been reported include: Clostridial infections, urinary tract infections, candidiasis, pneumonia cellulitis, upper respiratory tract infection and rhinitis. Blood disorders (e.g. anaemia, thrombocytopenia). Anaphylactic reactions, angioedemas, hypersensitivity. Anorexia, hyperkalaemia and dehydration. Confusion, sleep disorders, balance disorders, convulsions, hypoesthesia, memory impairment and attention disorders. Hypotension, hypertension and fainting. Hot flushes. Breathing difficulty, pleural effusion, COPD. Gastrointestinal disorders and skin reactions. Liver function test abnormalities. Dysuria, pollakiuria and proteinuria. Oedema. Pyrexia. INR abnormalities. Prescribers should consult the SmPC in relation to all adverse reactions. UNITED KINGDOM Legal category: POM Cost: Basic NHS price £259.23 for 56 tablets Marketing Authorisation holder: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK Marketing Authorisation number: PL 20011/0020 IRELAND Legal category: Prescription only Cost: €262.41 for 56 tablets Marketing Authorisation holder: Norgine B.V. Hogehilweg 7, 1101 CA Amsterdam ZO, Netherlands Marketing Authorisation number: PA 1336/009/001 For further information contact: Norgine Pharmaceuticals Limited, Norgine House, Moorhall Road, Harefield, Middlesex UB9 6NS Telephone: 01895 826 606 E-mail: Medinfo@norgine.com Ref: UK/XIF5/0119/0477 Date of preparation: January 2019 United Kingdom Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on: Tel. +44 (0)1895 826 606 Email Medinfo@norgine.com

Ireland Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on: Tel. +44 (0)1895 826 606 Email Medinfo@norgine.com References: 1. National Institute for Health and Care Excellence. Rifaximin for preventing episodes of overt hepatic encephalopathy: appraisal guidance TA337 for rifaximin. Available from: http://www.nice.org.uk/guidance/ta337 2. TARGAXAN® 550 Summary of Product Characteristics. Available for the UK from: https://www.medicines.org.uk/emc Available for Ireland from: www.medicines.ie 3. Mullen KD, et al. Clin Gastroenterol Hepatol 2014;12(8):1390-97. Product under licence from Alfasigma S.p.A. TARGAXAN is a registered trademark of the Alfasigma group of companies, licensed to the Norgine group of companies. NORGINE and the sail logo are registered trademarks of the Norgine group of companies. UK/XIF5/0219/0487 Date of preparation: February 2019.

GASTROENTEROLOGY TODAY - SUMMER 2019

UK&IE Prescribing Information: Targaxan 550mg (rifaximin-α) REFER TO FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING Presentation: Film-coated tablet containing rifaximin 550 mg. Uses: Targaxan is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age. Dosage and administration: Adults 18 years of age and over: 550 mg twice daily, with a glass of water, with or without food for up to 6 months. Treatment beyond 6 months should be based on risk benefit balance including those associated with the progression of the patients hepatic dysfunction. No dosage changes are necessary in the elderly or those with hepatic insufficiency. Use with caution in patients with renal impairment. Contraindications: Contraindicated in hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients and in cases of intestinal obstruction. Warnings and precautions for use: The potential association of rifaximin treatment with Clostridium difficile associated diarrhoea and pseudomembranous colitis cannot be ruled out. The administration of rifaximin with other rifamycins is not recommended. Rifaximin may cause a reddish discolouration of the urine. Use with caution in patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD (Model for End-Stage Liver Disease) score > 25. In hepatic impaired patients, rifaximin may decrease the exposure of concomitantly administered CYP3A4 substrates (e.g. warfarin, antiepileptics, antiarrhythmics, oral contraceptives). Both decreases and increases in international normalized ratio (in some cases with bleeding events) have been reported in patients maintained on warfarin and prescribed rifaximin. If co-administration is necessary, the international normalized ratio should be carefully monitored with the addition or withdrawal of treatment with rifaximin. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. Ciclosporin may increase the rifaximin Cmax Pregnancy and lactation: Rifaximin is not recommended during pregnancy. The benefits of rifaximin treatment should be assessed against the need to continue breastfeeding. Side effects: Common effects reported in clinical trials are dizziness, headache, depression, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. Other effects that have

COMPANY NEWS

THE INFECTION RISK IS REAL In 2010, Cantel (UK) Ltd became the first company to offer sterile single-use endoscope valves and in 2018 became the first supplier in the UK to provide sterile single-use valves compatible with GI endoscopes from Olympus, Pentax and Fujifilm.

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www.cantelmedical.co.uk References 1. Rutala, W.A., Weber, D. J., and the Healthcare Infection Control Practices Advisory Committee (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities (Last update: February 15, 2017). Retrieved from CDC: https://www.cdc.gov/ infectioncontrol/ pdf/guidelines/disinfection-guidelines.pdf 2. National costing statement: Infection prevention and control (2012,

DEFENDO Valves are high-performance, high-quality products that support procedural control and efficiency. Cantel’s verification testing includes multiple tests for force and suction to help create valves that don’t exhibit some of the common issues with reusable and other single-use valves: clogging, sticking and loss of insufflation. When you experience these issues during a procedure, the result can be a longer, more difficult procedure. With every guideline update, there is clear direction that singleuse accessories are highly recommended. The British Society of Gastroenterology guidance states “’Single-use’ accessories should always be used”4 and the recently updated ESGENA guidelines state that “endoscope valves can also show contamination after reprocessing and may be the source of infections if cleaning, drying, storage, and hand hygiene are inadequate. There is an increasing trend for using

GASTROENTEROLOGY TODAY - SUMMER 2019

March) 3. Pearce, P.J. (2011, August). A Report on the Widespread Inadequate Reprocessing of Endoscope Air/Water and Suction Valves by Healthcare Facilities. Retrieved from: http://www. medivators.com/sites/default/files/minntech/documents/ Improper%20Valve%20Reprocessing%20Study_Sept%20 2017_50098-1504%20Rev%20A.pdf 4. BSG. “Guidance for Decontamination of Equipment for Gastrointestinal Endoscopy.” (2016, November) 5. Reprocessing of flexible endoscopes and endoscopic accessories used in gastrointestinal endoscopy: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA) – Update 2018

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COMPANY NEWS IMPORTANT NEW TRIAL WITH ORAL FERACCRU® SHOWS COMPARABLE EFFICACY TO IV IRON (FERRIC CARBOXYMALTOSE), OFFERING A REAL ALTERNATIVE TO HOSPITAL ADMINISTRATION FOR MANY PATIENTS[4] • FERACCRU® (Ferric Maltol) met primary endpoint against Ferinject® (IV

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Anaemia have often tried a number of oral iron treatments which didn’t

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(IVI FCM), but without the need for hospital-based administration4

administration. Now many patients can be treated at home with an

• FERACCRU® was efficiently absorbed and well tolerated over the extended treatment period, in line with previous studies2 Shield Therapeutics plc (Shield) and Norgine B.V. (Norgine) have announced positive results from the AEGIS Head-to-Head (H2H) clinical trial, which compared FERACCRU® (ferric maltol), a novel oral iron replacement therapy, to Ferinject® (ferric carboxymaltose (FCM)), a market-leading intravenously delivered iron replacement therapy4. In the AEGIS-H2H study, ferric maltol demonstrated increases in the mean Hb levels that were comparable to IV FCM. Patients with Iron Deficiency Anaemia (IDA), whose Inflammatory Bowel Disease (IBD) is inactive now have an important alternative treatment option, which is both effective

effective and well-tolerated oral iron alternative,” he added. More detailed analyses of the data, including the secondary endpoints and safety parameters, will be presented at Shield’s upcoming presentation of its preliminary results for 2018, scheduled for early April 2019, whilst the full data will be submitted for peer-review and subsequent presentation by the study’s lead investigators at upcoming scientific meetings. FERACCRU® is a novel, effective and well tolerated treatment, which is approved and marketed in the European Union for the treatment of iron deficiency (ID) in adults and in Switzerland for the treatment of iron

over the long term and well tolerated, therefore reducing the need for

deficiency anaemia (IDA) in adults with inflammatory bowel disease

time-consuming and expensive hospital administration. Current oral iron

(IBD) 1-3. A New Drug Application in the USA is being reviewed by the

treatments can be poorly tolerated and don’t always work , which leads to

FDA with a PDUFA date of 27 July 2019.

many unwell patients having to receive IV iron in hospital. On 19 September 2018, Norgine entered into an exclusive licence “The results of this study provide an important opportunity to change

agreement with Shield Therapeutics plc for the commercialisation of the

clinical practice to improve patients’ lives. Patients with inactive

product in Europe, Australia and New Zealand.

WHY NOT WRITE FOR US? GASTROENTEROLOGY TODAY - SUMMER 2019

Gastroenterology Today welcomes the submission of clinical papers and case reports or news that you feel will be of interest to your colleagues. Material submitted will be seen by those working within all UK gastroenterology departments and endoscopy units. All submissions should be forwarded to info@mediapublishingcompany.com

If you have any queries please contact the publisher Terry Gardner via: info@mediapublishingcompany.com

COMPANY NEWS

GASTROENTEROLOGY TODAY - SUMMER 2019

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NORGINE NEW STUDY HIGHLIGHTS NEED TO INCREASE PUBLIC UNDERSTANDING OF IMPORTANT ROLE OF COLONOSCOPY IN PREVENTING AND DIAGNOSING GASTROINTESTINAL DISEASES, INCLUDING COLORECTAL CANCER • Those with no previous experience of colonoscopy were considerably more nervous about the procedure than those who had already undergone colonoscopy (74% vs 49%) • Current lack of public understanding around colonoscopy may be negatively impacting on number of eligible people attending their colonoscopy appointment • Less than half (45%) of those who had not had the procedure knew that a colonoscopy could prevent colorectal cancer

“This survey highlights the lack of information about colonoscopy in public domain. Clinicians need to provide easily accessible and clear information about colonoscopy to improve the uptake of bowel cancer screening program in our fight against colorectal cancer,” said Professor Pradeep Bhandari, Consultant Gastroenterologist, QA Hospital, Portsmouth. In the 50 years since the first colonoscopy, the procedure has become a crucial tool in the prevention and detection of gastrointestinal disorders, including colorectal cancer. Despite significant advances, however, the variation in uptake across Europe continues to prevent the potential of

AMSTERDAM, April 4, 2019 /PRNewswire/ -- NORGINE B.V. (Norgine)

colonoscopy being fully realised for patients and health systems.

today published the findings of a public survey at the European Society of Gastrointestinal Endoscopy (ESGE) Days in Prague as we celebrate

The survey asked 500 and 2500 people with and without colonoscopy

the 50th anniversary of the first colonoscopy. [1],[2],[3] This important study

experience across five main EU countries (UK, Germany, France, Spain

highlights the need to increase public understanding of the important

and Italy) about their experience and understanding of colonoscopy.

role of colonoscopy in the prevention and diagnosis of gastrointestinal

[1],[2],[3]

diseases including colorectal cancer. The survey was conducted across five major European countries and included both people who had

undergone a colonoscopy and those who have no previous experience

www.norgine.com

with the procedure. The study findings highlighted the misconceptions and strong negative associations about colonoscopy amongst those who have had no previous experience with the procedure. Those with no previous experience of colonoscopy were considerably more nervous about the procedure than those who had already undergone colonoscopy (74% vs 49%). This may be one of the reasons why many eligible people do not GASTROENTEROLOGY TODAY - SUMMER 2019

attend their colonoscopy appointments each year [4] - a vital procedure

References [1] Bhandari P, Amlani B, Radaelli F. ePP31 Public attitudes to colonoscopy: The purpose of colonoscopy. Presented at ESGE 2019, Prague. https://www.professionalabstracts.com/esge2019/ iplanner/#/presentation/336 Last accessed April 2019 [2] Amlani B, Bhandari P, Radaelli F. ePP92 Public attitudes to

for the prevention and diagnosis of gastrointestinal diseases, including

colonoscopy: Experience of colonoscopy. Presented at ESGE

colorectal cancer. The target population for colorectal cancer screening

2019, Prague. https://www.professionalabstracts.com/esge2019/

in the EU is close to 69,000,000, but only 14% of the target population is currently being screened.[4]

iplanner/#/presentation/409 Last accessed April 2019 [3] Bhandari P, Amlani B, Radaelli F. OP362 Public attitudes to

This study has highlighted the benefit of public education to increase

colonoscopy: Embarrassment levels and colonoscopy. Presented

understanding of the importance of the colonoscopy procedure, and

at ESGE 2019, Prague. https://www.professionalabstracts.com/

particularly its important role in preventing colorectal cancer. Less

esge2019/iplanner/#/presentation/890 Last accessed April 2019

than half (45%) of those who had not had the procedure knew that a colonoscopy could prevent colorectal cancer. Other findings suggested

[4] European Commission, Cancer Screening in the European Union,

the need to improve patient experience of the procedure, including

Report on the implementation of the Council recommendation on

bowel preparation and the provision of relevant information. This may

cancer screening, 2017. https://ec.europa.eu/health/sites/health/

provide an opportunity for healthcare professionals to further support

files/major_chronic_diseases/docs/2017_cancerscreening_2ndrepo

their patients.

rtimplementation_en.pdf Last accessed April 2019

COMPANY NEWS

driving scientific advancements in digestive health October 19-23, 2019 Venue: Fira Gran Via, Barcelona Ahead of UEG Week Barcelona 2019, UEG President Professor Paul Fockens discusses why he is looking forward to one of the world’s premier digestive health meetings.ngs. UEG Week is the largest and most prestigious gastroenterology meeting of its kind, with more than 14,000 delegates from over 110 countries worldwide.

The two-day Postgraduate Teaching Programme will provide profound updates on a wide range of gastrointestinal and hepatology topics that suit both gastroenterologists in training as well as established physicians and general practitioners. The programme focuses on the relevance for the clinical day-to-day business and enables participants to get perfectly prepared for their

UEG Week will once again host the hugely successful ‘Today’s Science, Tomorrow’s Medicine’ initiative and this year’s theme will be ‘Microbiota: Moving towards clinics’. Here, topclass scientists will be invited to discuss how current knowledge and thinking is ready to be used in clinical practice and establish strategies to foster further progression in this area. UEG Week provides an exceptional opportunity for investigators from around the globe to submit and present their latest findings. UEG will present a number of awards at the congress, including the Top Abstract Prizes, the UEG Research Prize and the UEG Rising Star Awards. I am anticipating a very exciting week of scientific advances and updates from leading digestive health experts and thoroughly look forward to welcoming new and returning delegates to UEG Week Barcelona 2019. To find out more, visit: ueg.eu/week

Benefit from reduced dele gate fees until September 5 , 2019

ing Late-break abstract submission ust opens Aug 19, 2019

GASTROENTEROLOGY TODAY - SUMMER 2019

The UEG Scientific Committee is developing a state-of-the-art scientific programme, featuring the latest advancements and most exciting research in digestive health. This will ensure the delivery of world-class presentations across a range of specialties, covering clinical, translational and basic science. An inclusive offering is provided for all attendees, whatever their level of expertise, featuring a broad variety of sessions that include symposia, live endoscopy and abstract-based sessions. Different interactive formats allow lively interaction between the audience, chairs and speakers.

professional career. 2019 marks year 3 of our rolling 3-year curriculum.

COMPANY NEWS

NEW CHIEF EXECUTIVE OFFICER ANNOUNCEMENT Coeliac UK, the national charity for people who need to live gluten free, has appointed Hilary Croft as its new CEO from 3 June 2019, succeeding Sarah Sleet. Ms Croft’s professional background lies in business transformation within complex, multifaceted organisations. Her senior management career started in marketing with Capgemini, a global leader in consulting, technology and digital transformation services, where she worked with a variety of organisations, such as Virgin Atlantic, Sky, Lego and Royal Mail. Hilary Croft also has vast knowledge and interest in the food and drink sector through previous positions with Marks and Spencer, Coca-Cola, Compass Group and World Duty Free Europe. More recently, as CEO of the Felix Project, she developed significant partnerships with food suppliers and re-distributers to reduce food waste and food poverty across London. About her appointment, Ms Croft said: “I am excited to be taking up the CEO role at Coeliac UK, a charity with a truly unique health and food scope. I look forward to developing the charity’s strong reputation, bringing fresh ideas and strategic insights. Naturally, my direct experience of coeliac disease, through my son’s condition, further motivates me to achieve real and lasting change for the gluten free community.”

Mike Elliott, Coeliac UK’s Chair of Governors, said: “Hilary’s business and strategic acumen will bring new drive and impetus at this exciting time in Coeliac UK’s journey. The charity is currently entering a new ten year strategic review and requires an experienced change leader to adapt to a constantly evolving, complex environment. We feel Hilary is exceptionally qualified to lead Coeliac UK into the future and we look forward to welcoming her.” Ms Croft is also a trustee of Age UK Ealing and a global fundraising committee member for Tearfund, a charity that helps communities around the world escape the very worst effects of poverty and disaster. About Coeliac UK Coeliac UK campaigns for better access to diagnosis of coeliac disease and funds critical research into potential cures. It provides expert and independent information to 65,000 members to manage their health and gluten free diet. The charity also fights for wider availability of gluten free food by working with food manufacturers, service providers and venues. Currently 3,000 products and 200 companies use the charity’s Crossed Grain certification scheme and 3,200 food outlets, cafés and restaurants have achieved its Gluten Free accreditation. In 2018, the charity’s total income was £4.1m with research expenditure increasing from £204k to £496k.

WHY NOT WRITE FOR US? Gastroenterology Today welcomes the submission of clinical papers and case reports or news that you feel will be of interest to your colleagues. GASTROENTEROLOGY TODAY - SUMMER 2019

Material submitted will be seen by those working within all UK gastroenterology departments and endoscopy units. All submissions should be forwarded to info@mediapublishingcompany.com

If you have any queries please contact the publisher Terry Gardner via: info@mediapublishingcompany.com

THE GUT HEALTH EXPERTS COMPANY NEWS

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NORGINE: NEW REAL WORLD STUDY SHOWS RIFAXIMIN-A SIGNIFICANTLY REDUCED HOSPITALISATION IN PATIENTS WITH OVERT HEPATIC ENCEPHALOPATHY (HE) WHEN ADDED TO LACTULOSE • Rifaximin-a in combination with lactulose, the standard of care (SOC) treatment resulted in significant reductions (p<0.001) in both HE related hospital admissions and length of hospital stay • Rifaximin-a also showed good efficacy in the management of patients with liver disease with the complication of HE based on real-world data AMSTERDAM, April 15, 2019 /PRNewswire/ -- Norgine B.V. today highlighted results of a real world study showing significant reductions in the number and length of hospitalisations when rifaximin-a is added to lactulose, the SOC treatment for patients with overt hepatic encephalopathy (HE).[1] The findings, borne out in real world evidence, come from an independent, investigator initiated study, presented today at the International Liver Congress (ILC) in Vienna. The study compared the progress of 127 patients in their first six months of combination treatment with rifaximin-a with the prior six months when treated with lactulose alone.[1] “Adding rifaximin-a to standard treatment was proven to significantly reduce episodes of hepatic encephalopathy in liver disease patients and keep patients out of hospital for longer, compared to lactulose alone” said Dr. Rosalie C. Oey, Lead Investigator of the study. “Preventing the recurrence of HE is extremely important for patients’ quality of life and the findings highlight the prophylactic value of rifaximin-a in the long-term management of the disease.”

GASTROENTEROLOGY TODAY - SUMMER 2019

Marko Korenjak, President, European Liver Patients’ Assosiation (ELPA) commented, “Hepatic encephalopathy is a very serious and frightening complication for both patients and their carers and significantly impacts on people’s quality of life. The European Liver Patients’ Assosiation welcomes research that may enhance the availability of treatment options which potentially benefit patients and reduce the burden on healthcare systems.” HE is a serious, potentially life-threatening chronic condition associated with liver cirrhosis.[2] HE is a significant complication of advanced chronic liver disease and occurs in up to 40% of patients and often remains under-diagnosed and under-treated.[3],[4] HE is debilitating and can significantly impact the life of patients and their carers. People with liver disease who develop HE are approximately twice as likely to die, when compared with liver disease patients without the condition over the same time period. [5] Follow us @norgine www.norgine.com

References [1] Oey, R.C. et al, The efficacy and safety of rifaximin-a: a 2-year observational study of overt hepatic encephalopathy, Presented at , International Liver Congress (ILC) 2019, Vienna SAT-092 [2] Morgan M. Chapter 8: Hepatic Encephalopathy in Patients with Cirrhosis. In: Dooley JS, Lok A, Burroughs A, Heathcote J, editors. Sherlock’s Diseases of the Liver and Biliary System. 12th ed: Blackwell Publishing Ltd; 2011 [3] Hepatic Encephalopathy in Chronic Liver Disease: 2014 Practice Guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. Journal of Hepatology 2014; 61(3):642-659 [4] Mullen KD. Review of the final report of the 1998 Working Party on definition, nomenclature and diagnosis of hepatic encephalopathy. Aliment Pharmacol Ther. 2007 Feb;25 Suppl 1:11-6 [5] Morgan, C.LI et al, Mortality associated with hepatic encephalopathy in patients with severe liver disease, Hepatology 2014; 60 (Abstract P452): S219 GL/COR/0419/0188, Date of preparation April 2019

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GASTROENTEROLOGY TODAY - SUMMER 2019

Helicobacter Test INFAI ® The most used 13C-urea breath test for the diagnosis of Hp-infection worldwide

• more than 4.5 million INFAI tests performed in Europe • approved for children from the ages of 3 to 11 • special INFAI test for patients with dyspepsia taking PPIs • cost-effective CliniPac Basic version for hospital use INFAI Institute for Biomedical Analysis & NMR Imaging, INFAI UK Ltd Innovation Centre, University Science Park, University Road, Heslington, YORK YO10 5DG, UK Phone +44 1904 435 228 - Fax +44 1904 435 229 - mail: info@infai.co.uk - Visit us at www.infai.com