Page 1

Volume 29 No. 3

Autumn 2019

Gastroenterology Today Passionate about Endoscopy? We are clearing NHS trust waiting lists one weekend at a time, and we need your help

18 Week Support Gastroenterology: Building Expert Teams

In this issue An unusual case of oesophagitis Assessment of thyroid profile in patients with fissure in ANO


Life feels good when Crohn’s is under control 1,2

Entocort® CR is indicated for the induction of remission in adults with mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon3

Oral modified-release budesonide preparations are formulated to target specific types of inflammatory bowel disease. To ensure your patient receives a budesonide indicated for Crohn’s disease, prescribe Entocort ® CR by brand. 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, 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

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. Entocort® CR 3mg Capsules – Summary of Product Characteristics. November 2018. Date of preparation: January 2019. PU-00237.


CONTENTS

CONTENTS

What approach has 18 Week Support taken with regards toGastroenterology building an Today expert insourcing team? This issue edited by: Andy Poullis c/o Media Publishing Company Matthew’s Perspective: Media House Dr Matthew Banks is the Clinical Director for 18 Week Support Gastroenterology. He believes it starts with recruiting the 48clinicians High whose Street best clinicians. ‘At 18 Week Support we set the bar very high. We only recruit JAG performance data is well above the national standards. In addition, we monitor each clinician’s KPIsSWANLEY, while they workKent with 18BR8 WS. While the JAG data 8BQ

5

EDITORS COMMENT

6

CASE REPORT An unusual case of oesophagitis

8

is an excellent quality indicator, we now want to go a step beyond that and monitor the Non-Technical skills (NTS) of each FEATURE A  ssessment of thyroid profile in patients with clinician as well. We now know that NTS plays an important role in safe and effective team performance. Therefore, in our ADVERTISING & CIRCULATION: fissure in ano in the South quest Indian population to develop excellent teams who deliver a world-class service, we must focus on NTS’.

15

NEWS

28

BSG POSTERS

30

COMPANY NEWS

Media Publishing Company Media House, 48 High Street Tammy Kingstree is Lead Nurse for Endoscopy. SWANLEY, Kent, BR8 8BQ ‘It is extremely important that there are good working relationships within the team. This starts with strong leadership from Tel: manage 01322a team 660434 01322 666539 our senior nurse coordinators who are trained to manage the patient pathway, of staff Fax: they may not know and to deal effectively with any issues which may arise on the day’. E: info@mediapublishingcompany.com www.MediaPublishingCompany.com Tammy and Lisa’s Perspective:

Lisa Phillips is Lead Nurse for Endoscopy.

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

PUBLISHING DATES: 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. February,

June and October.

If you have an excellent NHS record and want to help clear NHS waiting list backlogs, reduce RTT waiting times and provide

COPYRIGHT: high-quality patient care, get in touch by calling on 020 3892 6162 or email Gastro.Recruitment@18weeksupport.com

COVER STORY 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. 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

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 Spring 2020 Subscription Information – Autumn 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

GASTROENTEROLOGY TODAY - AUTUMN 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’.

Media Publishing Company Media House 48 High Street SWANLEY, Kent, BR8 8BQ

3


TVEG & GENIE Presents

A STUDY DAY Sponsored by 7th December 2019

The specialised area of Gastroenterology/Endoscopy is an area where we pride ourselves with working alongside the British Society of Gastroenterology (BSG). The BSG aims to provide quality improvement to create the same level of care for patients and provide high standards therefore protocols and policies are updated on a regular basis. So even when working for a NHS Trust or a company like 18 Week Support, all Endoscopy units adhere to BSG, JAG (Joint Advisory Service) and GRS (Global Rating Score). With this in mind, staff in either a private sector or the NHS needs to be updated. The whole team from the Consultants to Clinical Nurse Endoscopists and the endoscopy nurses require these resources to keep updated, therefore the most efficient way is education. Education is at the forefront of Health especially with the changes in recent times, such as the Nursing and Midwifery Council revalidation process and the Darzi report and recommendations. It’s vital to support our workforce with up-to-date events to provide high quality education. The education group TVEG (Thames Valley Endoscopy Group) and GENIE (Gastroenterology Endoscopy Nurses in Essex) have been running for over 25yrs, merging together to cover a large area of Essex, London and the surrounding areas. We have provided annual study days for Endoscopy Nurses and of late Specialist and Nurse Endoscopists. So that we can capture all regions, in the past we have held studies in varying trusts. Education is vital to provide high quality services and have members of the team working with up to date knowledge and endeavor to make across all NHS trusts to the same standards. Therefore, it’s with great privilege this year to team up with 18 Week Support to give another outstanding study day. We have grown immensely over the years and with their continuing commitment, we hope to get NHS and the 18 Week Support staff to provide an even higher quality service to NHS trusts.

Holding the study day on a Saturday opens it up for all to attend and everyone is grateful for the speakers giving up their time. The program for this event will be released in November, tickets will be sold via Eventbrite, feel free to attend. Lunch and Refreshments will be provided We will provide expert advice on latest updates, tips and tricks with hands on techniques and, as always popular, we will have live Endoscopy from Professor of Gastroenterology Prof Mathew Banks and Clinical Nurse Endoscopist Sr Sara Brogden. Could you please send any enquires to sara.brogden@nhs.net Delegates must all be working within Endoscopy/Gastroenterology and the attendance will be capped at 125- 130 delegates. This study day is run as a charity. Please note, if you already work shifts with 18 Week Support and visit their stand or if you successfully apply to work with 18 Week Support on the day and complete a shift by the 31st of March 2020 you will be able claim your attendance fee back.

Yours sincerely, Sara E M Brogden (Chair of TVEG & GENIE)

About you If you have an excellent NHS record and want to help clear NHS waiting list backlogs, reduce RTT waiting times and provide highquality patient care, get in touch by calling on 0203 966 9081 or email us at recruitment@18weeksupport.com

Our mission: giving up-to-date education, providing current criteria, quality and commitment to all. 18 Week support will help to provide this, showing that we can continue improving care and support to our health professional patients, and trusts and continue to work with the key points of BSG, JAG and GRS. This year the study day will be held on Saturday 7th December 2019 at the 1st Floor Educational Centre University College Hospital, 250 Euston Road, NW1 2PG

www.18weeksupport.com London 3rd Floor, 19-21 Great Tower Street London | EC3R 5AR | 020 3869 8790


EDITORS COMMENT

EDITORS COMMENT Gastroenterology Today going from strength to strength

“If unsure on the suitability of an article or case report then please feel free to contact the editorial office so we can give advice.”

I am pleased to be able to bring a range of reports, features and news in this edition of GT. We have had an increase in submitted articles enabling us to bring a range of articles. Another case report from St George’s reminding us all that occasionally reflux symptoms have slightly more to them.... An interesting report from India reminds us that, in the population studied, systemic disease still can manifest with local/bowel symptoms. Our news section highlights a number of dynamic initiatives in the world of gastroenterology. At GT we want to fully support all aspiring gastroenterologists and are also keen to support submissions. If unsure on the suitability of an article or case report then please feel free to contact the editorial office so we can give advice. We accept a wide variety of materials from personal view, mini-reviews, case reports, studies to news of important GI related events. We are pleased to announce that we will be moving back to 4 publications a year due to interest in the journal and the volume of work submitted. I think I have achieved the impossible - an editorial without reference to the NHS pension disaster or Brexit!! Andy Poullis St George’s Hospital, London

GASTROENTEROLOGY TODAY - AUTUMN 2019

5


CASE REPORT

AN UNUSUAL CASE OF OESOPHAGITIS K Punjabi, V Vakeeswarasarma, A Poullis Department of Gastroenterology, St George’s Hospital

Abstract We report a case of a patient with multisystem systemic lupus erythematosus (SLE), requiring immunosuppressant therapy, who presented with symptoms of gastro-oesophageal reflux a year after starting Mycophenolate Mofetil (MMF). An initial gastroscopy showed severe oesophagitis with ulceration with oesophageal biopsies showing chronic inflammation. Treatment was initiated with high dose

PCR for EBV DNA carried out on oesophageal biopsies confirmed the diagnosis of EBV oesophagitis a year after initial presentation and the patient was initiated on valcyclovir 1g three times a day for one month. On this treatment the reflux symptoms gradually resolved. At endoscopic follow up there was significant improvement to the oesophageal inflammation and biopsies returned negative for EBV DNA. At clinical follow up she remains well.

proton pump inhibitor therapy and the addition of a histamine receptor antagonist when no endoscopic improvement was identified. Repeat oesophageal biopsies suggested a possible infective element to the gastro-oesophageal reflux. Polymerase chain reaction (PCR) detected EBV DNA in serology (at 160 IU/ml) and on oesophageal biopsies. A diagnosis of EBV oesophagitis was made and treated with a one month course of Valcyclovir. On initiation with this treatment the reflux symptoms rapidly resolved. Following the diagnosis, the dose of MMF was reduced. Further repeat PCR on blood and biopsy samples have returned negative. Oesophageal manifestation of EBV are rarely reported and should be considered in patients with oesophageal ulceration at endoscopy not responding to anti-reflux medications. Diagnosis is most sensitive with polymerase chain reaction testing rather than cellular pathological examination or serological markers to allow for prompt management.

Discussion Infective oesophagitis in a healthy individual is a relatively rare condition. However, the prevalence rises in certain high-risk populations, such as those with a compromised immune system. Infection could also be secondary to other causes, such as diabetes mellitus, malignancy, gastro-oesophageal reflux disease (GORD) or chronic corticosteroid use (1). Causes of infective oesophagitis can be sub-divided into bacterial, viral and fungal. Risk factors can range from immunosuppressive conditions or chemotherapies, neutropenia, antimicrobial therapy and HIV infection (2,3). Infectious agents can get in contact with the oesophageal mucosa either by direct contact, through lymphatics and vascular systems, or by direct extension from adjacent mediastinal structures (2).

Case History A 43 year old woman was initially referred to gastroenterology clinic for symptoms of indigestion and burning reflux one year after initiating Mycophenolate Mofetil (MMF). She was under various speciality teams for SLE with multisystem involvement, including Sjogren’s syndrome, GASTROENTEROLOGY TODAY - AUTUMN 2019

6

The most common cause is the fungal infection Candida albicans. Candida is a dimorphic yeast and usually invades tissue by the formation of hyphae in the distal third of the oesophagus, leaving behind superficial yellow-white plaques. This infection is likely to be found in patients with acquired immunodeficiency syndrome (3) and steroid use.

interstitial lung disease, nephrotic syndrome, and neurologic SLE.

Bacterial oesophagitis is less common than fungal and is usually found

Initially she was managed on azathioprine but changed to MMF after

in sites of oesophageal mucosal disruption, likely secondary to acid

renal biopsy confirmed SLE membranous nephritis, which was titrated

reflux (4). As mentioned, this incidence increases when a person is

to 1.5g twice a day and a background low dose prednisolone was

immunocompromised. Normal oesophageal flora consists of gram-

continued. Her initial gastroscopy showed severe oesophagitis with

positive bacteria, commonly Streptococci viridans. However, this can

ulceration and biopsies showed chronic inflammation so was started

change to gram-negative due to reflux, leading to more complications

on high dose omeprazole at 40mg twice a day, which only partially

(5). In immunocompromised patients, bacterial infection can be

improved the reflux symptoms. A repeat gastroscopy showed severe

polymicrobial, and in some cases of HIV patients, mycobacterial.

oseophagitis, so her therapy was changed to esomprazole 40mg once a day and ranitidine 150mg once a day. Biopsies at follow up

Cytomegalovirus (CMV) is one of the commonest viral causes for

suggested it was more than simple severe gastro-oesophageal reflux

infective oesophagitis, usually occurring in patients post solid organ

and suggestive of an infective aetiology.

transplant (1). These patients are often given prophylactic treatment, however despite this, there is still a proportion that develop delayed

A serological viral screen identified a reactive HSV-1 IgG, suggesting

onset CMV infection. Herpes Simplex Virus infection type 1 (HSV-

a recent HSV infection, but a negative HIV, EBV IgM and CMV. Viral

1) is typically the cause over HSV-2 for oesophageal infection. On

polymerase chain reaction (PCR) identified 160 IU/ml of EBV DNA.

endoscopy, diagnostic raised edge ulcers are seen, forming a punched


CASE REPORT out or volcano-like appearance. PCR on biopsy samples can confirm

3. Asayama N, Nagata N, Shimbo T, Nishimura S, Igari T, Akiyama J et al. Relationship between clinical factors and severity of esophageal

the diagnosis (6).

candidiasis according to Kodsi’s classification. Diseases of the In this case, EBV was the cause of the oesophagitis. EBV is thought to activate immune-mediated mechanisms which ultimately leads to tissue damage (7). During investigation, it is important not to solely rely on a standard peripheral blood exam and routine histopathology, as this may lead to an incorrect diagnosis (8). Diagnosis can be confirmed with PCR on biopsy specimens. On endoscopy, there is ulceration, which differs

Esophagus. 2013;27(3):214-219. 4. Radhi J, Schweiger F. Bacterial oesophagitis in an immunocompromised patient. Postgraduate Medical Journal. 1994;70(821):233-234. 5. Yang L, Francois F, Pei Z. Molecular Pathways: Pathogenesis and

from HSV as the ulcers seen are usually deeper, more linear and located

Clinical Implications of Microbiome Alteration in Esophagitis and

in the mid-oesophagus. The main management is with acyclovir therapy,

Barrett Esophagus. Clinical Cancer Research. 2012;18(8):2138-

which should lead to resolution of the oesophagus confirmed with a

2144.

repeat endoscopy (9). 6. Lee B. A rare cause of dysphagia: Herpes simplex esophagitis. Oesophagitis due to EBV infection should be considered in patients with recurrent symptoms and endoscopic appearance of oesophageal ulceration. Our case identifies the significance of PCR testing of biopsy samples to allow for prompt diagnosis and appropriate management.

World Journal of Gastroenterology. 2007;13(19):2756. 7. Pape M, Mandraveli K, Sidiropoulos I, Koliouskas D, Alexiou-Daniel S, Frantzidou F. Unusual Epstein-Barr esophageal infection in an immunocompetent patient: a case report. Journal of Medical Case Reports. 2009;3(1):7314.

References

8. Annaházi A, Terhes G, Deák J, Tiszlavicz L, Rosztóczy A, Wittmann T et al. Fulminant Epstein–Barr virus esophagitis in an

1. O’Rourke A. Infective oesophagitis. Current Opinion in Otolaryngology & Head and Neck Surgery. 2015;23(6):459-463. 2. De Prez C. Oesophagites infectieuses. Acta Endoscopica. 2002;32(2):119-123.

immunocompetent patient. Endoscopy. 2011;43(S 02):E348-E349. 9. Baehr P, McDonald G. Esophageal infections: Risk factors, presentation, diagnosis, and treatment. Gastroenterology. 1994;106(2):509-532.

POSTER SUBMISSIONS

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

GASTROENTEROLOGY TODAY - AUTUMN 2019

If you have submitted a poster to this years BSG or ENDOLIVE events and would like it published in Gastroenterology Today please forward a PDF of your poster to the email address listed below.

7


FEATURE

ASSESSMENT OF THYROID PROFILE IN PATIENTS WITH FISSURE IN ANO IN THE SOUTH INDIAN POPULATION Saveetha Institute of Medical and Technical Science, Chennai, India Madhumitha Prabhakaran, Bharath N, Arcot Rekha

Abstract

Objectives

Keywords: Hypothyroidism, Fissure in ano, Anal fissure,

1. To determine the incidence of patients with lower gastrointestinal

constipation, thyroid profile, lower gastrointestinal complaints

symptoms attending the surgical outpatient department. 2. To find the incidence of fissure in ano among patients with lower

Background: A precipitating history of constipation is found in approximately 20% of patients with anal fissures. Hard feces result in local trauma to the rectal mucosa which in turn secondarily

gastrointestinal symptoms attending the surgical outpatient department. 3. To analyze the pattern of thyroid profile in patients with fissure in ano

activates internal anal sphincter hypertonia. As the maximum resting anal pressure (MRAP) is usually greater than 90 mm Hg in patients with fissures such hypertonia will compress these end arteries and cause ischemia of the posterior commissure and eventually anal fissures. Constipation is one of the classic signs of hypothyroidism. The most probable pathological reason is the intestinal edema due to mucopolysaccharide accumulation in gastrointestinal tissue. Method: This is a prospective, observational study. We first identified the male and female patients presenting to the outpatient department with various lower abdominal complaints. Informed consent for inclusion in the study was obtained. A thyroid assay was ordered for all the anal fissure patients who were admitted for surgical procedures. Result: 38.2% of patients with lower gastrointestinal complaints and 3.6% of the total number of patients presenting to the surgical OPD were attributed to an anal fissure. The incidence of hypothyroidism in patients with an anal fissure is 32%. Since GASTROENTEROLOGY TODAY - AUTUMN 2019

8

the incidence of hypothyroidism in our study is higher than the prevalence of hypothyroidism in the general population as documented by multiple studies in the past, we can conclude that there is a significant association between hypothyroidism and development of anal fissures. Conclusion: By analyzing the thyroid profile in patients with anal fissures, we found an association between the two entities. This information can be used to predict and prevent anal fissures in hypothyroid patients.

Background An anal fissure is defined as split in the mucosa extending from the anal verge to the dentate line. The fissures usually present with pain and rectal bleeding. A precipitating history of constipation is found in approximately 20% of patients with fissure in ano. Hard feces result in local trauma to the rectal mucosa which in turn secondarily activates internal anal sphincter hypertonia. Subsequent sphincter spasm leads to further constipation and a vicious cycle is created. Treatment modalities such as anal dilatation and internal sphincterotomy aim to break this cycle by disrupting the internal anal sphincter. [1] The posterior midline of the anus is supplied by end arteries which pass through the internal anal sphincter before reaching the posterior commissure. The mean arteriolar blood pressure of the end arteries is 85 mm Hg. As a result, it is thought that the blood flow to this area is potentially deficient. [2] Fissure in ano patients have maximum resting anal pressure (MRAP) greater than 90 mm Hg usually. This state of hypertonia will compress the end arteries, leading to ischemia of the posterior commissure and finally anal fissures. [3] Some might say that hypertonia arises secondary to pain. But the inability to provide relief from the hypertonia by using painkillers disproves this theory. [4] Constipation is one of the many classic signs of hypothyroidism. The pathophysiological changes observed in the digestive tracts

Aim

of hypothyroid patients have not been definitely determined, but according to recent studies, a deficiency of thyroid hormone weakens the contractions of the muscles that line the digestive

To study the thyroid profile of patients presenting to the surgery

tract. The most probable pathological reason is the accumulation of

OPD with constipation and a diagnosis of fissure in ano.

mucopolysaccharides, especially hyaluronic acid in the gastrointestinal


FEATURE tissue leading to intestinal edema. This reduction in the motor activity delays the intestinal transit time of feces which allows more water absorption and eventually causes constipation. [5] This evidence supports the hypothesis that an important etiological factor of anal fissures is hypothyroidism causing constipation.

Methods We first identified the male and female patients presenting to the outpatient department with various lower abdominal complaints like lower gastrointestinal bleeding, painful defecation, constipation, or mass descending per rectum. These patients were then diagnosed with constipation, hemorrhoids, malignancy, fistula, abscess, or fissure in ano. The fissure in ano patients were further classified as per their age distribution.

TABLE 1: Diagnosis of male patients presenting with lower gastrointestinal complaints Constipation

34

Hemorrhoids

43

Malignancy

3

Fistula

11

Abscess

18

Fissure in ano

80

TOTAL

189

Diagnosis of male patients presenting with lower gastrointestinal complaints

TABLE 2: Age distribution of male patients diagnosed with fissure in ano 18% 2

<20 years

Informed consent for inclusion in the study was obtained. A thyroid assay was ordered for all the fissure in ano patients who were admitted for surgical procedures. Patients with TSH values higher than the

42%

20-29 years

40-59 years

labeled as hypothyroid.

>60 years

The prevalence of hypothyroidism is identified in the public population

TOTAL

Hemorrhoids

30

30-39 years

reference range or T3/T4 values lower than the reference range were

Constipation

23%

24

Fistula

22 9%

6%

Abscess

2 80

Malignancy

Fissure in ano 2%

using previously done studies and compared with the prevalence of hypothyroidism in our patients with fissure in ano.

A total of 1497 female patients presented to the surgical OPD during the study period, of which 127 had lower gastrointestinal complaints.

Result

CHART 2: Diagnosis of female patients presenting with lower gastrointestinal complaints

A total of 3332 patients presented to the Surgical OPD during the study period, of which 316 presented with lower gastrointestinal complaints. The incidence of lower gastrointestinal complaints in our surgical OPD

32%

was 9.4%. Of the 316 patients with lower gastrointestinal complaints,

33%

Constipation Hemorrhoids

121 were diagnosed with fissure in ano. 38.2% of patients with lower

Malignancy

gastrointestinal complaints and 3.6% of the total number of patients presenting to the surgical OPD were attributed to fissure in ano.

Fistula

9% 23%

A total of 1835 male patients presented to the surgical OPD during the

Abscess Fissure in ano

study period, of which 189 had lower gastrointestinal complaints.

Diagnosis of male patients presenting with lower gastrointestinal complaints TABLE 3: Diagnosis of female patients presenting with lower gastrointestinal complaints 18% 42% 23%

Constipation

Constipation

42

Hemorrhoids

Hemorrhoids

29

Malignancy

2

Fistula

1

Abscess

12

Fissure in ano

41

TOTAL

127

Malignancy Fistula

9%

6%

Abscess Fissure in ano 2%

GASTROENTEROLOGY TODAY - AUTUMN 2019

1% 2%

9 CHART 2: Diagnosis of female patients presenting with lower gastrointestinal complaints


FEATURE TABLE 4: Age distribution of female patients diagnosed with fissure in ano <20 years

4

20-29 years

21

30-39 years

13

40-59 years

2

>60 years

1

TOTAL

41

Conclusion Lower gastrointestinal symptoms form a significant proportion of people attending the surgical outpatient department out of which one third are diagnosed with fissure in ano. The patients present with various types and degrees of symptoms and complications all of which are distressing. This positive association can be used to encourage screening of patients diagnosed with fissure in ano for thyroid derangements. Also patients diagnosed with hypothyroidism can be advised to manage their constipation to prevent anal fissures.

A total of 50 patients with fissure in ano were admitted for surgical procedures and their thyroid assay was subsequently done. 16

Conflict of Interest: None

patients had hypothyroidism characterized by increased free TSH values and low free T3 and free T4 according to the reference range. The incidence of hypothyroidism in patients with fissure in ano is 32%.

References 1. McCallion K, Gardiner KR. Progress in the understanding and

Discussion Fissures were more common in the age group of 20 to 40

treatment of chronic anal fissure. Postgraduate medical journal. 2001 Dec 1;77(914):753-8. 2. Klosterhalfen B, Vogel P, Rixen H, Mittermayer C. Topography of

years with an incidence of 67.5% in males and 82.9% of

the inferior rectal artery: a possible cause of chronic, primary anal

females attending the surgical outpatient department with lower

fissure. Diseases of the Colon & Rectum. 1989 Jan 1;32(1):43-52.

gastrointestinal complaints. 3. Prohm P, Bönner C. Is manometry essential for surgery of According to a study done by Unnikrishnan et al in eight cities

chronic fissure-in-ano?. Diseases of the colon & rectum. 1995 Jul

in India, the overall prevalence of hypothyroidism was 10.95%.

1;38(7):735-8.

A significantly higher proportion of females with 15.86% as compared to males with 5.02% were diagnosed. [6] In the present study, the incidence of hypothyroidism is significantly higher. In a population-based study done in Cochin on 971 adult subjects, the prevalence of hypothyroidism was 3.9%. The prevalence of subclinical hypothyroidism was high in this study as well with 9.4%. In women, the prevalence was higher(11.4%), when compared with men (6.2%). [7] Our study has an incidence of 32% which is higher. GASTROENTEROLOGY TODAY - AUTUMN 2019

10

The prevalence of hypothyroidism in India is 11%, 2% in the UK and 4·6% in the USA. Coastal cities like Mumbai, Goa, and Chennai, have a higher prevalence (11·7%) than cities located inland (9·5%). [8] The present study has a higher incidence of hypothyroidism. In a study done by Velayutham et al, 11% of young females in the south Indian population had elevated TSH levels. [9] In the present study, the incidence is 32%.

4. Minguez M, Tomas-Ridocci M, Garcia A, Benages A. Pressure of the anal canal in patients with hemorrhoids or with anal fissure. Effect of the topical application of an anesthetic gel. Revista espanola de enfermedades digestivas: organo oficial de la Sociedad Espanola de Patologia Digestiva. 1992 Feb;81(2):103-7. 5. Yaylali O, Kirac S, Yilmaz M, Akin F, Yuksel D, Demirkan N, Akdag B. Does hypothyroidism affect gastrointestinal motility?. Gastroenterology research and practice. 2009;2009. 6. Unnikrishnan AG, Kalra S, Sahay RK, Bantwal G, John M, Tewari N. Prevalence of hypothyroidism in adults: An epidemiological study in eight cities of India. Indian journal of endocrinology and metabolism. 2013 Jul;17(4):647. 7. Unnikrishnan AG, Menon UV. Thyroid disorders in India: An epidemiological perspective. Indian journal of endocrinology and metabolism. 2011 Jul;15(Suppl2):S78. 8. Bagcchi, Sanjeet. “Hypothyroidism in India: more to be done.” The Lancet Diabetes & Endocrinology 2.10 (2014): 778.

Since the incidence of hypothyroidism in our study is higher than the prevalence of hypothyroidism in the general population as

9. Velayutham K, Selvan SS, Unnikrishnan AG. Prevalence of

documented by multiple studies in the past, we can conclude that

thyroid dysfunction among young females in a South Indian

there is a significant association between hypothyroidism and

population. Indian journal of endocrinology and metabolism. 2015

development of fissure in ano.

Nov;19(6):781.


FEATURE

Water-based food supplement with

Live & Active Bacteria

to help support the gut microbiome

Arrive

Survive

Thrive

Multi-strain bacteria arrive in a live and active state, ready to act in the gut

Water-based nature survives stomach acid, allowing the bacteria to reach the gut intact

Clinically proven to rapidly multiply in the gut, contributing to gut microbiome balance

Dairy Free

Suitable for Vegans and Vegetarians

L

No Added Colours

www.symprove.com

GASTROENTEROLOGY TODAY - AUTUMN 2019

L L L

Gluten Free

11


POSTERS

Endoscope reprocessing: we’re only human We’re only human was an American movie directed by James Flood and released in 1935. Even then, there was great interest in shifting from human work to automated assembly lines. But what does this have to do with the reprocessing of flexible endoscopes? In my opinion, it is related to today’s reprocessing problems of these complex medical devices. For decades we have known that flexible endoscopes – even when cleaned and disinfected can be a source of debris, biofilm and thus micro-organisms, leading to serious infection problems. Just take a look at the headlines about contaminated, so called ‘superbug’, endoscopes. However, manual reprocessing is still underestimated and reprocessing staff are only human.

The importance of endoscopy Since the introduction of the first flexible endoscope in 1956 by Basil Hirschowitz and Larry Curtis, the number of procedures using these devices has increased enormously. Only in the United States approximately 75 million procedures were performed in 2017 [idataresearch.com, 28 may 2018]. And it is expected that this number will increase in the next decades. A procedure with a flexible endoscope has many advantages compared to traditional procedures and they are very safe. Of course, like any other procedure, there are also potential complications like perforation, bleeding, pancreatitis (as a result of ERCP) or infection. Focusing on the last one, these infections can originate from the patients own bacterial flora, or from exogenous flora, transmitted by a previously used endoscope.

GASTROENTEROLOGY TODAY - AUTUMN 2019

12

Complex, reusable devices Flexible endoscopes are complex, reusable medical devices. During a procedure they can become highly contaminated with organic materials and bacteria. Studies have showed a high bacterial contamination inside the channels of sometimes more than 10^9 CFU per channel (one billion colony forming units) [Rutala WA, Weber DJ. Reprocessing endoscopes: United States perspective. J Hosp Infect. Apr 2004;56 Suppl 2: S27-31. Kaczmarek RG et al. Am J Med 1992;92:257-261]. Flexible endoscopes need to be thoroughly reprocessed between each patient, to guarantee a safe subsequent use. Simultaneously with the technical development, extensive use of endoscopes and identified outbreaks due to contaminated endoscopes, techniques for cleaning and disinfection were improved. One of the most important innovations in endoscopy was the introduction of high-level disinfection of endoscopes [Sivak MV. Gastrointestinal endoscopy: past and future. GUT. 2006, Aug; 55(8), 1061-1064). The role of automated endoscope-disinfectors With the introduction and increased usage of automated high-level endoscope-disinfectors, practitioners developed

an utopic belief that the problem of contaminated endoscopes would belong to the past. Now that the reprocessing process was automated, controlled, and could be retrieved and validated. Practitioners thought that manual cleaning was not necessary anymore with these endoscope-disinfectors - which also contained a cleaning and increased rinsing stage, with reduced human failures in reprocessing. However, reality was different: even with the use of these disinfectors, outbreaks due to contaminated endoscopes kept occurring. Endoscopes were still not clean enough after reprocessing [Kovaleva, 2013]. This is not a surprise. Underestimated manual cleaning With only flushing water with detergent to disinfectant through the channels, automated endoscope-disinfectors were not able to remove any debris, biofilm and thus micro-organisms. Although some endoscope-disinfectors claim a 90% reduction of debris in the first step inside cleaning [Alfa et al, 2006], the manual cleaning before automated cleaning and disinfection is still the most important step [Beilenhoff, ESGE-ESGENA 2018]. Manual brushing and flushing of the endoscope, using the right procedures and techniques, removes > 90% of all debris, biofilm and micro-organisms [Chu NS, McAlister D, Antonoplos PA. 1998. Natural bioburden levels detected on flexible gastrointestinal endoscopes after clinical use and manual cleaning. Gastrointest. Endosc. 48:137–142]. The last 10% can be removed by the automated endoscope-disinfector. However, in daily practice, the manual cleaning stage is downgraded to just a simple flush and brush, despite all reported outbreaks and the detailed IFUs for manual cleaning. The question is: why? Time pressure in reprocessing units Since the number of endoscopic procedures is increasing enormously, there is a great pressure on the availability of reprocessed endoscopes. With the high turnover of endoscopes, time has become the key factor in many endoscopy wards and reprocessing units. After use,


POSTERS

endoscopes should be available as fast as possible. There is a continuous pressure to reduce reprocessing times. Every minute counts. Also in the manual cleaning stage, and even in the drying stage. Ofstead et al showed that in 45% of cases key steps in reprocessing are skipped. In less than 50%, manual cleaning and drying - the two most critical steps - are performed according to instructions [Ofstead et al. Endoscope reprocessing methods. A prospective study of human factors and automation. Gastrointestinal Nursing. 2010; Vol 33. No 4, pp 304-311]. In reality, only a few minutes are invested in flushing, brushing, inspection and the leak test, without following all steps of the reprocessing manual. Also, it is known that when working under high pressure mistakes can increase. Of course, we are only human. 75% of the reprocessing staff reported on a time pressure and non-compliance with guidelines related to reprocessing as a result [Beilenhoff U et al. Reprocessing in GI Endoscopy: ESGE-ESGENA Position Statement. Endoscopy 2018; 50]. For decades we have known that time pressure sometimes leads to reported outbreaks of infection. But what has been done to reduce the risk? Okay, there were some critical reports, guidelines were improved and recently an automated, video controlled, cleaning unit (UltraZonic®) was introduced to increase effectiveness and standardization. Hereby eliminating human failures as a nice side effect. However, the required reprocessing is still a point of discussion – especially amongst managers.

to ensure compliance to reprocessing guidelines [Beilenhoff U et al. Reprocessing in GI Endoscopy: ESGE-ESGENA Position Statement. Endoscopy 2018; 50]. But it is easier said than done: it is remarkable and even perplexing that we still do not invest enough in continuous training of the people reprocessing those complex instruments on a daily basis. Not only to eliminate human failures, but to improve quality and safety in endoscope reprocessing as well. Resulting in less risks of exogenous infections due to an improperly cleaned and disinfected endoscope. Shift from quantity to quality I call upon the field, to shift from reprocessing quantity to quality. Despite all innovations, such as disposable ERCP tips (Pentax), new drying and storage systems like the PlasmaTYPHOON, or even upcoming disposable endoscopes, the human factor will always stay important. Quoting Alibabafounder Jack Ma ‘Computers have only chips. Humans have a heart. And it’s the heart in which wisdom is originated’. It is never too late to invest in human capital, especially when reprocessing complex medical devices like flexible endoscopes.

Training the human capital We need to invest in training our personnel continuously. It is well known that intensified training of endoscopists (physicians) and nurse endoscopists is a successful way to improve diagnosis and treatment, which might result in better patient outcome [UEG, June 2014]. A recent survey shows a positive effect in training reprocessing staff and regular audits

Paul J Caesar (Tjongerschans Hospital, Heerenveen, the Netherlands) Expert in infection control, sterile medical devices and reprocessing flexible endoscopes

GASTROENTEROLOGY TODAY - AUTUMN 2019

Fingers pointed in the wrong direction We are all pointing at the manufacturers. They have developed complex, difficult to clean endoscopes and their reprocessing manuals are hard to understand and on average more than a hundred pages long, including over 150 steps. In my opinion we are turning the world upside down. Of course, flexible endoscopes are complex devices, and design flaws can lead to problems, even of infectious origin. However, outbreaks related to flexible endoscopes are only in 8% related to the design of flexible endoscopes [Kovaleva, 2012]. It is possible to clean, disinfect and dry endoscopes adequately following the manufacturer’s instructions for use (IFUs) at all times. [Muscarella et al. World J Gastrointestinal Endosc. 2014. October 16; 6(10): 457-474 ISSN 1948-5190]. But we need to be willing to invest time, dedicated and qualified personal, and the right equipment and resources.

13


NEWS

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

GASTROENTEROLOGY TODAY - AUTUMN 2019

14

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 deficiency. 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 deficiency 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 efficacy 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 inflammatory bowel disease (IBD) flare 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.

Before starting treatment, iron deficiency or iron deficiency anaemia (IDA) diagnosis should be made based on blood tests; it is important to investigate the cause of the iron deficiency and to exclude underlying causes of anaemia other than iron deficiency. Feraccru contains lactose and so patients with rare hereditary problems of galactose intolerance, total lactase deficiency 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, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine), moxifloxacin, mycophenolate, norfloxacin, ofloxacin, 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, flatulence, 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, Harefield, 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: September 2019. UK/FER/0719/0083.


NEWS The taboo subject of constipation: undermining patient’s quality of life and putting a preventable strain on NHS The Bowel Interest Group launches 2019 ‘Cost of Constipation’ report 26th July 2019 - Independent multidisciplinary organisation The Bowel Interest Group has released its ‘Cost of Constipation’ report revealing the impact that the taboo subject of constipation has on the UK. This latest report not only explores the significant cost of constipation to the NHS but highlights the damaging impact on

constipation in 2017/18. This cost is likely to

house for social activities. In addition to the

be much higher when GP visits, home visits

physical problems constipation can cause

and over the counter laxatives are taken into

such as haemorrhoids, chronic pain and

account. Specifically, the report shows that:

urinary tract infections, the report highlights the high incidence of anxiety disorders and

• In 2017/18, 71,430 people with

depression in people with constipation.

constipation were admitted to hospital in England. This is equivalent to 196 per day. • Close to three quarters of these were unplanned emergency admissions, equivalent to 144 per day. • £91 million was spent on prescription laxatives in 2017/18. • The cost of treating constipation in 2017/18 is equivalent to funding 7043 newly-qualified nurses for a year. • On average, 6.3 people visit a GP about constipation each week.

patient lives.

Dr Benjamin Disney, Consultant Gastroenterologist, University Hospitals Coventry and Warwickshire NHS Trust, comments: “Many people see constipation as a simple, straightforward, easily treated condition that does not greatly affect people. However, from the Cost of Constipation report and my clinical experience, this is often not the case, with the condition being under-reported and often poorly managed, leading to a significant cost to the NHS and having a negative impact on patients’ overall health and quality of life. The Bowel Interest Group aims to tackle and raise awareness of the important issue of constipation.”

The Cost of Constipation report also lays

The report shows that poor bowel health and

bare the embarrassment and distress

Patients, clinicians and other interested

chronic constipation, which are debilitating

caused by the condition, revealing that

parties may download the full report

for hundreds and thousands of people in

one in five people are embarrassed to talk

free of charge by visiting: https://

the UK, cost the NHS a preventable £71

about constipation with their GP, and some

bowelinterestgroup.co.uk/cost-of-

million in unplanned hospital admissions for

people find themselves unable to leave the

constipation-report-2019-public.

The Complete FIT Solution Numerous publications now demonstrate the high NPV performance of faecal immunochemical testing (FIT) with symptomatic patients for cancer, HRA and IBD.

Forr the best support in establishing your FIT service contact the experts for a full end-to-end solution: ■ Simple, hygienic sample collection device □ Stabilises faecal haemoglobin: □ 14 days at ambient, 120 days at 2-8C ■ Assay with excellent low end sensitivity - 7 ng/ml ■ Custom designed patient instructions ■ Complete patient packs ■ Logistics solutions tailored to your requirements

Everything you need to know about FIT: W: faecal-immunochemical-test.co.uk | E: digestivedx@alphalabs.co.uk The FIT Solution_Oct_19.indd 1

19/09/2019 12:04:56

GASTROENTEROLOGY TODAY - AUTUMN 2019

Alpha Laboratories has partnered with many of the FIT pioneers to further expand the knowledge of the use of FIT for symptomatic patients. For example, THE NICE FIT STUDY (www.nicefitstudy.com) has now generated over 11,500 data sets, doubling the data reviewed by NICE across 10 studies. With many new publications in print, or pending publication, confirming the recommendations of NICE DG30, the application of this test is helping to optimise patient pathways in many healthcare trusts.

15


NEWS Northern Ireland patients first to use exercise in overcoming treatment for deadliest common cancer Northern Ireland pancreatic cancer patients will be the first in the UK to trial an innovative new exercise programme to aid their recovery from the traumatic 12hour operation needed to save their lives, after researchers from Queen’s University Belfast were awarded a grant of more than £100,000 from Pancreatic Cancer UK. The grant from Pancreatic Cancer UK’s Research Innovation Fund is the charity’s first

effects of chemotherapy. The burden of these symptoms can damage a patient’s recovery as well their long-term health and wellbeing.

if it is successful, the project has significant potential to improve the quality of life for patients who have surgery, an area of research that has previously been under-developed because of the urgent need to find new treatments and improve diagnosis. Pancreatic cancer has the lowest survival of all common cancers, with less than seven per cent of people with the disease in Northern Ireland living for five years. Surgery is the only cure for pancreatic cancer but it can have a traumatic impact on patients. The procedure involves removing all or part of the pancreas and making major changes to the digestive system, meaning patients can experience serious side effects - including pain, fatigue and anxiety - in addition to the

and had a massive impact on my recovery. Not everyone can do it but it’s well worth doing your best. You will feel the benefit.”

Researchers will work extensively with local pancreatic cancer patients who have had surgery to design bespoke exercise programs tailored toward managing each individual’s symptoms. Exercise has previously been shown to benefit patients with other cancers such as breast and prostate, but the two-year study by Queen’s University will be the first time it has been trialled with those treated for pancreatic cancer. Patients will be supported in undertaking resistance and aerobic exercise at their own pace, alongside post-operative chemotherapy. It is hoped that a successful trial in Belfast will see the project expand to other sites in the UK benefiting more patients.

ever investment in a research project based in Northern Ireland. The charity believes that,

me made me so much stronger in every way

Dromore, County Down resident Tom Hawthorne knows all about the impact of the operation. He was diagnosed with pancreatic cancer in August 2017 and quickly scheduled for surgery. He credits cycling with helping him to overcome the side effects. Tom, 61, said: “I was told that it was going to be a pretty tough operation but at that stage I did not fully grasp what that actually meant. For me, the operation was totally devastating - it was really tough, physically and psychologically. “From my first day out of intensive care I was determined to give it my best shot after speaking to my surgeon. From blowing that little pipe to keep the ball up, to family helping me around the corridors and friends helping me to the park, it all helped me so much. Then eventually getting back on my bike. All this for

Dr Chris MacDonald, Head of Research at Pancreatic Cancer UK, said: “Research into pancreatic cancer has been grossly underfunded for decades, stifling innovation and delaying the breakthroughs we so badly need to see. The potential positive impact of this project devised by the team at Queen’s University Belfast is hugely exciting and I am delighted it is our first-ever funded research in Northern Ireland. “While it can be lifesaving, the combination of such extensive surgery followed by chemotherapy can take a heavy toll. It may sound counterintuitive, but exercise could be key to mitigating many of the symptoms that affect a patient’s quality of life. We are determined to explore innovative ideas such as this one to ensure patients can make the fullest possible recovery.” The research at Queen’s University Belfast is one of six promising new projects to receive a grant from Pancreatic Cancer UK’s Research Innovation Fund in 2019. Grants are intended to help combat the cycle of underfunding which has hampered desperately needed progress on diagnosis, treatment and survival for pancreatic cancer. By funding cutting-edge projects, Pancreatic Cancer UK helps researchers take their work to the next stage of development and closer to much-needed breakthroughs. Since its creation Pancreatic Cancer UK’s Research Innovation Fund has awarded more £2 million to research projects, which have gone on to attract more than £14 million of additional funding.

GASTROENTEROLOGY TODAY - AUTUMN 2019

Dr Gillian Prue, Lead Researcher from the School of Nursing and Midwifery at Queen’s University Belfast, said: This is a fantastic opportunity for people with pancreatic cancer in NI and we are very grateful to Pancreatic Cancer UK for their support. We hope that by undertaking a supervised exercise programme during chemotherapy patients may avoid an almost inevitable decline in function. Increasing activity levels may help patients tolerate chemotherapy treatment and reduce treatment side effects. This is the first time a study such as this has been undertaken in the UK, so we will be working very closely with our patients to ensure the programme is achievable and meets their needs.”

16


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

NEWS

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 - AUTUMN 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

17


NEWS Rising stars of Gastroenterology & Hepatology honoured at the 2019 Dr Falk Pharma/Guts UK Awards An investigation into why and how normal colon cells mutate into cancer, how best to reduce the harm caused by blood borne liver viruses in prisons and the potential benefits of faecal microbial transplantation (FMT) in the

Professor Chris Hawkey, President of Guts UK

apply research findings in the clinical setting to

Charity, who co-presented the ceremony says:

improve patient care’

‘These awards have supported numerous

Advanced Dietitian in Paediatric

medical students, junior doctors, nurses

Gastroenterology, Ms Isobel Connolly won

and dietitians at crucial early stages in their

the Dietitian Award for her work establishing

careers. These are the most talented health

a dietetic-led clinic for paediatric patients

professionals and leaders of tomorrow and

with Coeliac Disease. Her Manager, Principle

support at this early stage helps to signal their

Paediatric Dietician Nicole Dos Santos explained:

potential to them and their peers and foster self-belief as the bright stars of tomorrow. The

‘This service has improved patient care

awards continue to be highly competitive and

significantly by increasing patient access

help to attract the brightest and the best to the

to follow up and decreasing the number of

field of UK gastroenterology.

appointments patients require, improving patient attendance and streamlining dietetic

treatment of chronic liver disease. These are

‘Guts UK is delighted to continue its collaboration

just a few of the highly significant research and

with Dr Falk Pharma UK, and the Trustees of

clinical projects explored by the ten worthy

Guts UK greatly value Dr Falk’s clear vision and

Dr Riadh Jazrawi, Medical Director of Dr Falk

winners of the 2019 Dr Falk Pharma UK/Guts

ongoing support of this valuable initiative.’

Pharma UK and co-presenter of the Awards commented:

UK Charity Awards. The winners, who included medical students, junior doctors, nurses and

Ms Jaclyn Tan was awarded the Medical Student

dietitians were presented with their awards

Prize for her project focussing on the diagnosis

‘This year, as always, we take huge pleasure

during a dinner on Tuesday June 18th at the

and management of patients with spontaneous

in being able to reward and support the talent,

bacterial peritonitis (SBP), a frequent and severe

work ethic and passion displayed by these

complication with a high mortality rate in patients

young medical students and doctors.

British Society of Gastroenterology (BSG) Annual Meeting in Glasgow. Now in their 13th year, the Dr Falk Pharma UK/ Guts UK Charity Awards have become widely recognised within the gastroenterology and hepatology community for the support and endorsement they offer junior doctors starting

with cirrhosis and ascites. ‘We sincerely hope that, in doing so, we can ‘It is a great honour to be awarded the Dr

support and encourage them into become

Falk/Guts UK Medical Student Prize,’ said Ms

the next generation of hepatologists and

Tan, who will return to take up her 4th year of

gastroenterologists.

medicine at the University College Medical School in September.

out on their careers. Through nurse and

GASTROENTEROLOGY TODAY - AUTUMN 2019

18

review with blood monitoring.’

‘We are also delighted to honour the commitment displayed by our nurse and

dietitian prizes, the awards also acknowledge

‘This has fuelled my drive to undertake

dietitian award winners, who often in their own

and reward the innovation and dedication that

further work within the discipline, as I strive

time, instigate innovative projects that lead to

these HCPs bring to their patients.

to contribute to the scientific community and

great benefits for patients.’


NEWS

GASTROENTEROLOGY TODAY - AUTUMN 2019

19


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

PBC expertise is closer than you think...

1 21 2

Consider referral to 1 of 26 PBC hubs in England or a Liver Centre comprised of specialist multidisciplinary teams for individualised patient treatment and second-line therapy.

3

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

14 25

4

6 11 7 23

9

15

32

12

24

16

17 29

28

10

5

Find your nearest Liver Centre at www.britishlivertrust.org.uk/ liver-information/useful-links/ liver-and-transplant-units/ 2. Ninewells Hospital, Dundee

8

26

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

1.

13

18

33 31

20

22 27 19

30

Liver Centres PBC Hubs

15. Leeds Teaching Hosp NHS Trust 16. Manchester University NHS FT 17. Nottingham Univ Hosp NHS Trust 18. Oxford Univ Hosps NHS FT

13. King’s College Hosp NHS FT

19. Portsmouth Hosps NHS Trust

14. Imperial College Healthcare Trust

21. Royal Free London NHS FT

20. Royal Devon & Exeter 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 33. Royal Gwent Hospital, Newport

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 - AUTUMN 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 co-administration 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 breastfeeding 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

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

20 1.

EASL guidelines. J Hepatol. 2017;67:145–172. UK-PP-PB-0464 September 2019

fertility effects. Undesirable effects: Very common (≥1/10) adverse reactions were pruritus, fatigue, and abdominal pain and discomfort. The 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 International Ltd, 31–36 Ormond Quay Upper, Dublin 7, Ireland Package Quantities and Basic NHS cost: OCALIVA 5 mg and 10 mg £2,384.04 per bottle of 30 tablets. Date of revision: 10th June 2019

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 Okayama University research: Early gastric cancer endoscopic diagnosis system using artificial intelligence (Okayama, 15 July) Researchers at

(Convolutional Neural Network) published by Google on numerical analysis software MATLAB. Next, the researchers used the ResNet, which is a 152-layer convolutional neural network, to conduct intramucosal endoscopic resection among patients treated for early gastric cancer at Okayama University Hospital.

Okayama University have developed an early gastric cancer endoscopic diagnosis system using artificial intelligence (AI). The details were presented at the Congress of the Japan Gastroenterological Endoscopy Society (JGES), May 31 – June 2, 2019, Tokyo. According to data released in 2017 by Japan’s Ministry of Health, Labor, gastric cancer ranks third in cancer deaths in Japan: second in men and fourth in women. Treatment of early-stage gastric cancer includes endoscopic surgery (ESD), which can save the stomach, and surgical procedures that require gastrectomy.

Using endoscopic images of 100 cancers (M group) and 50 submucosal invasion cancers (SM-ESD group) and 50 submucosal invasion cancers (SM-OPE group) who had undergone surgery from the beginning, the researchers built the AI system and verified its diagnostic accuracy. The diagnostic accuracy of intramucosal cancer by artificial intelligence diagnostic system was sensitivity 82.7%, specificity 63.0%, positive predictive value 69.1%, negative predictive rate 78.4% in image unit, and sensitivity 82.0% in case unit. The specificity was 71.0%, the positive predictive value was 73.9%, and the negative predictive value was 79.8%.

In addition, the correct diagnosis rate for deep-seated diagnosis of early gastric cancer as a combination of intramucosal cancer and submucosal invasion cancer was 72.8% in image units and 76.5% in case units. Implications of the research At present, gastroenterological endoscope medical diagnosis and treatment is based on experienced practicing physicians examining images. As a result, the diagnostic ability of individual doctors varies, and with increases in the number of medical services in the future, there is concern about the possibility of oversight of cancer and increases in misdiagnosis. If automatic diagnosis of digestive tract endoscope images by AI is realized, then ‘automated diagnosis logic’ will be added to endoscope technology for real time diagnosis. Automatic diagnosis will be possible and it will greatly improve the current status of relying on the diagnostic ability of individual endoscopy physicians.

However, although advances in endoscopic treatment technology has led to the early detection of gastric cancer, decisions on whether to use endoscopy treatment or surgery mainly depend on how deep the cancer has invaded the stomach wall. Furthermore, these decisions are made by careful examination of endoscopic images by experienced physicians. At present, there are many cases where endoscopic treatment is performed first where surgery would have been more appropriate and vice versa.

Kawahara of the Graduate School of Medical and Dental Sciences, Okayama University, and colleagues have developed artificial intelligence (AI)-based endoscope for early detection of gastric cancer. These research results were presented at the 97th Congress of the Japan Gastroenterological Endoscopy Society (JGES), May 31 – June 2, 2019, Tokyo. First the prototype of the system to obtain the depth of early gastric cancer was constructed with GoogLeNet to match purpose (metastatic learning) by using

GASTROENTEROLOGY TODAY - AUTUMN 2019

With this background, Professor Yoshiro

the image recognition ability of CNN

21


NEWS How intestinal bacteria can cause depression

headed by the neuropharmacologist and

of the project was to clarify how certain

neurogastroenterologist Peter Holzer from

bacteria in the gut alert the immune system

Graz was able to identify a number of concrete

and thus trigger a feeling of illness. “The

factors that can trigger psychological changes

immune system learns early on to tolerate

in mice in a recently completed basic-research

the microorganisms in the gut. That starts

A research group from Graz is investigating

project funded by the Austrian Science Fund

in infancy,” explains Holzer. “When some

the complex interaction between the

FWF.

substances produced by bacteria penetrate the intestinal wall, this certainly creates an

intestine and the brain. In a project funded by the Austrian Science Fund FWF, the team

Intestine affects the brain

immune reaction and, associated with it, a

has gained new insights into how intestinal

“The connection between the intestinal nervous

sense of being ill.” Specifically, he investigated

bacteria, the immune system and obesity

system and the brain has been known for a

the so-called “endotoxin lipopolysaccharide”

can lead to mental illnesses.

long time, but the situation has become more

(LPS), which is released by certain intestinal

complex if you consider the most recently

bacteria and stimulates the immune system,

It has been known for quite some time that

published studies,” says principal investigator

giving us a sense of being ill.

the proverbial “gut feeling” has a real medical

Peter Holzer. “In addition to the direct neural

basis. The intestine has its own nervous

pathways between intestine and brain, which

“If you suffer an infection with bacteria you will

system, also known as the “abdominal brain”

we have known about for a long time, there are

feel tired, have muscle pain, lose your appetite

owing to its size and complexity, and it is

many intestinal hormones that carry messages

and become withdrawn. This is a sensible

closely connected to the brain. Processes in

to the brain, as well as a huge immune system

reaction of the body, helping it to cope quickly

that releases messenger substances when

with the infection,” says the researcher.

stimulated. In recent years, the gut microbiota

“There is evidence, however, that this reaction

has become an additional factor. This consists

could be triggered in humans by intestinal

of a huge number of monocellular organisms

bacteria, even when there is no infection at

that also release substances and are believed

all.” Holzer’s team were able to show that other

to play an important role in the body’s

substances produced by bacteria, so-called

the intestine cause changes in the brain and, conversely, psychological factors influence the intestine. How far this interaction goes and how exactly it works, however, has not yet been fully understood. There are indications that the

intestine may be involved in the development system.” According to Holzer, 26/01/2019 Page 1 ofGastroToday_Jan_2019_v4 psychiatric diseases. A research group 09:39 information many people are

“peptidoglycans”, enhance the effect of LPS. “We believe that lipopolysaccharide is only

familiar with a

one of several factors contributing to the

strong connection

development of mental illness.”

between brain

GASTROENTEROLOGY TODAY - AUTUMN 2019

22

and gut. “But we

High-fat diet as a risk factor for depression

are not usually

Holzer sees this physical reaction of “feeling

aware of such

ill” in the larger context of intestinal influences

an amount of

on the human psyche, and in particular as a

information

possible trigger for psychiatric diseases. “We

reaching the brain

know from psychiatry and nutritional science

from the gut. This

that being overweight increases the risk of

information is fed

depression and depressive mood disorders.

into brain areas

Moreover, it has also been known for about 15

that are important

years that there is a great difference between

for our mood and

the gut microbiota of healthy and severely

emotions.”

overweight people,” Holzer notes. One result of the project provides concrete information

Feeling ill

on how processes in the intestine can trigger

because of

depressive behaviour.

bacteria in the intestine

The team subjected mice to a high-fat diet

Holzer and

and analysed their behaviour. In addition to

his team have

the chemical changes in the brain that are

spent five years

associated with depression, they also detected

investigating

concomitant behavioural changes. According

various signalling

to Holzer, it is difficult but not impossible to

pathways

detect this in mice. “Depressive people lose

which intestinal

their joy in certain things. This anhedonic, or

processes can

listless, behaviour was something we were

use to influence

able to identify in the mice that were given a

the brain.

high-fat diet.” Their method was to offer the

One objective

mice regular water and sugar water as an


NEWS alternative. Whereas healthy mice prefer sugar

immune and brain activity markers, in: Brain,

report on biologic therapies, and we hope

water, the mice in Holzer’s experimental setup

Behaviour and Immunity 44, 2015

that it gives a sense of how clinical and data

went for it much less often. In the next step, their gut microbiota was severely depleted

management in IBD has been changing for

Inflammatory Bowel Disease - first Annual Report on the Use of Biologics in IBD, published by the IBD Registry

the better, both more widely and over many

signalling pathway to explain how depressive

The IBD Registry, one of the largest clinical

“The report also makes references to a larger

behaviour can be triggered by a high-fat diet.

registries in Europe for Inflammatory Bowel

clinical dataset captured by the Registry which

The hormone “leptin”, which is released by

Diseases, has launched its first Annual

aims to provide a picture of the care received

fat cells, seems to play a role here. Mice that

Report on the Use of Biologic Therapies in England & Wales.

by people with IBD over time. We hope the

are unable to produce this hormone gain the

by the administration of antibiotics to find out whether intestinal microbes contributed to depressive behaviour after a high-fat diet. The results are due to be published soon. Fat hormone as a trigger

years. For example, vital information used by clinicians to treat patients is increasingly captured for the Registry’s database at the point of care rather than retrospectively, with the associated benefits of greater accuracy of information on a patient’s disease experience.

Holzer’s team has also identified a possible

results and commentary prove of interest to

same amount of weight as other mice when they eat high-fat foods, but tend not to show

The Registry, a not-for-profit company, is

the behaviour associated with depression.

responsible for running the National Audit

“The role of leptin has not yet been clearly

of Biological Therapies in IBD, targeted at a

settled in the literature. We were able to show

group of diseases which affect around half a

at least that leptin is important in this context.”

million people in the UK.

linked to short-chain fatty acids produced by

The purpose of the report is to consolidate in

microorganisms in the intestine from fibre-rich

one place annual changes and trends across

food. The microbiota of the intestine therefore

a basket of key performance indicators used

also seems to play an important role in the

in the Biological Therapies Audit in IBD and is

context of depression induced by obesity.

based on a dataset from 73 participating IBD

Personal details

IBD, as well as to the 500,000 people living with these diseases. “Finally, the IBD Registry would like to thank all those who have contributed to making this

Holzer suspects that the release of leptin is

treatment centres in

clinicians and others involved in managing

report a reality, above all our partner IBD clinical teams around the country who provided the information on which the report is based.” The report will be available on the IBD Registry website as a PDF at www.ibdregistry.org.uk

England Wales.

Peter Holzer is Professor of Experimental Neurogastroenterology at the Medical

The report includes

University of Graz and Head of the Research

the cumulative results

Unit for Translational Neurogastroenterology.

up to January 2019

For three decades his research has

from April 2016 when

focussed on the communication between the

the Registry assumed

gastrointestinal tract and the brain.

the role of supporting the National Audit

Publications

of Biological

Hassan AM, Mancano G, Kashofer K, Fröhlich

Therapies from the

EE, Matak A, Mayerhofer R, Reichmann F,

Royal College of

Olivares M, Neyrinck AM, Delzenne NM, Claus

Physicians.

like behaviour in mice associated with changes

It is expected the

in microbiome, neuropeptide Y, and brain

year-on-year changes

metabolome, in: Nutritional Neuroscience 2018

will be primarily

Fröhlich EE, Farzi A, Mayerhofer R, Reichmann

of interest to IBD

F, Jacan A, Wagner B, Zinser E, Bordag N,

clinicians but also

Magnes C, Fröhlich E, Kashofer K, Gorkiewicz

possibly to some

G, Holzer P.: Cognitive impairment by

patients, industry,

antibiotic-induced gut dysbiosis: analysis of

healthcare managers

gut microbiota-brain communication, in: Brain,

and others involved in

Behaviour and Immunity 56, 2016

IBD services.

Farzi A, Reichmann F, Meinitzer A, Mayerhofer R, Jain P, Hassan AM, Fröhlich EE, Wagner

Dr Stuart Bloom,

K, Painsipp E, Rinner B, Holzer P.: Synergistic

Registry Medical

effects of NOD1 or NOD2 and TLR4 activation

Director, said, “This

on mouse sickness behavior in relation to

is our first annual

Bring family & friends together and hold a stripy or red and white themed event. Register today for a Free fundraising pack. Email: info@sepsisresearch.org.uk Call: 07379 989 191 Together we can Sock it to Sepsis. #stopsepsisnow

www.sepsisresearch.org.uk Sepsis Research (FEAT) SCIO is a registered charity SC049399 and relies on the generosity of legacies and donations to help fund research and awareness of sepsis

GASTROENTEROLOGY TODAY - AUTUMN 2019

SP, Holzer P.: High-fat diet induces depression-

Join our ‘Sock It to Sepsis’ campaign to raise funds for vital research into sepsis.

23


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.

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.

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.

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.

Indication: For bowel cleansing in adults, prior to any procedure requiring a clean bowel.

If patients experience severe bloating, abdominal distension, or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms subside.

GASTROENTEROLOGY TODAY - AUTUMN 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.

24

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.

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/0919/0180 Date of preparation: September 2019


NEWS 88mm x 247mm (PI) CMYK

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

New Finnish study: dietary cholesterol or egg consumption do not increase the risk of stroke A new study from the University of Eastern Finland shows that a moderately high intake of dietary cholesterol or consumption of up to one egg per day is not associated with an elevated risk of stroke. Furthermore, no association was found in carriers of the APOE4 phenotype, which affects cholesterol metabolism and is remarkably common among the Finnish population. The findings were published in the American Journal of Clinical Nutrition. Findings from earlier studies addressing the association of dietary cholesterol or egg intake with the risk of stroke have been contradictory. Some studies have found an association between high dietary cholesterol intake and an increased risk of stroke, while others have associated the consumption of eggs, which are high in cholesterol, with a reduced risk of stroke. For most people, dietary cholesterol plays a very small role in affecting their serum cholesterol levels. However, in carriers of the apolipoprotein E phenotype 4 – which significantly impacts cholesterol metabolism – the effect of dietary cholesterol on serum cholesterol levels is greater. In Finland, the prevalence of APOE4, which is a hereditary variant, is exceptionally high, with approximately one third of the population presenting as carriers. Yet, research data on the association between a high intake of dietary cholesterol and the risk of stroke in this population group has not been available until now. The dietary habits of 1,950 men aged between 42 and 60 years with no baseline diagnosis of a cardiovascular disease were assessed at the onset the Kuopio Ischaemic Heart Disease Risk Factor Study, KIHD, in 1984–1989 at the University of Eastern Finland. APOE phenotype data were available for 1,015 of the men participating in the study. Of those, 32% were known carriers of APOE4. During a follow-up of 21 years, 217 men were diagnosed with stroke. The study found that neither dietary cholesterol nor egg consumption was associated with the risk of stroke – not even in carriers of APOE4. The findings suggest that moderate cholesterol intake or daily egg consumption are not associated with the risk of stroke, even in persons who are genetically predisposed to a greater effect of dietary cholesterol on serum cholesterol levels. In the highest control group, the study participants had an average daily dietary cholesterol intake of 520 mg and they consumed an average of one egg per day, which means that the findings cannot be generalised beyond these levels. One egg contains approximately 200 mg of cholesterol. In this study, about a fourth of the total dietary cholesterol consumed came from eggs. Furthermore, the generalisability of this study is also weakened by the fact that the study population did not have a pre-existing cardiovascular disease at baseline and the size of the

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

study population was relatively small. Therefore, the findings of the study should be verified in a larger cohort as well as in people with a pre-existing cardiovascular disease, who are currently advised to

GASTROENTEROLOGY TODAY - AUTUMN 2019

UK AND IE PRESCRIBING INFORMATION: Moviprep and Moviprep Orange (Macrogol 3350, sodium sulfate anhydrous, ascorbic acid, sodium ascorbate, sodium chloride and potassium chloride) PLEASE REFER TO THE FULL SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) BEFORE PRESCRIBING. Presentation: Powder for oral solution contained in two separate sachets, A and B. Sachet A contains macrogol 3350 100g; sodium sulfate anhydrous 7.5g; sodium chloride 2.691g and potassium chloride 1.015g. Sachet B contains ascorbic acid 4.7g and sodium ascorbate 5.9g. Uses: Bowel cleansing prior to any clinical procedure requiring a clean bowel. Dosage and administration: For oral use. Adults and Older People: A course of treatment consists of two litres of Moviprep / Moviprep Orange. A litre consists of one sachet A and one sachet B dissolved together in water to make one litre of solution. The reconstituted solution should be drunk over a period of one to two hours. This process should be repeated with a second litre 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 in the evening before and one litre in the early morning of the day of the clinical procedure. Ensure consumption of Moviprep / Moviprep Orange 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 in the evening before the clinical procedure or two litres in the morning of the clinical procedure. Ensure consumption of Moviprep / Moviprep Orange 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 in the evening before and one litre in the early morning of the day of the clinical procedure. Ensure consumption of Moviprep / Moviprep Orange 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 in the evening before the clinical procedure or two litres in the morning of the clinical procedure. Ensure consumption of Moviprep / Moviprep Orange 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 below 18 years of age. Contraindications: 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 including Crohn’s disease and ulcerative colitis. Do not use in unconscious patients. Warnings and precautions: 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 (creatinine clearance <30 mL/min), cardiac impairment (NYHA grade III or IV), those at risk of arrhythmia (e.g. those on treatment for cardiovascular disease or who have thyroid disease), dehydration, severe acute inflammatory bowel disease. Dehydration, if present, should be corrected before using Moviprep / Moviprep Orange. The reconstituted Moviprep / Moviprep Orange does not replace regular fluid intake and adequate fluid intake must be maintained.Semi-conscious patients or patients prone to aspiration or regurgitation should be closely monitored during administration, particularly if this is via a nasogastric route. If symptoms indicating arrhythmia or shifts of fluid or electrolytes occur, plasma electrolytes should be measured, ECG monitored 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 a 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 Orange is not recommended for patients with glucose-galactose malabsorption. Moviprep / Moviprep Orange contains 56.2 mmol of absorbable sodium per litre (caution in patients on a controlled sodium diet) and 14.2 mmol of 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. Fertility, pregnancy and lactation: There are no data on the effects on fertility. There are no data on the use in pregnancy or lactation so it should only be used if judged essential by the physician. Effects on ability to drive and use machines: No influence on the ability to drive and use machines. Side Effects: Very common: abdominal pain, nausea, abdominal distension, anal discomfort, malaise and pyrexia. Common: sleep disorder, dizziness, headache, vomiting, dyspepsia, rigors, thirst and hunger. Uncommon: dysphagia, abnormal liver function tests and discomfort. Not known: allergic reaction including anaphylactic reaction, dyspnoea and allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema; electrolyte disturbances including blood bicarbonate decreased, hyper and hypocalcaemia, hypophosphataemia, hypokalaemia and hyponatremia and changes in the blood chloride levels; dehydration; convulsions associated with severe hyponatraemia; transient increase in blood pressure; arrhythmia, palpitations; flatulence and retching. Refer to the SmPC for a full list and frequency of adverse events. UNITED KINGDOM: Price and pack sizes: Lemon- or orange-flavoured powder in sachets, 1 treatment pack (2 x sachet A + 2 x sachet B) £10.36. Legal category: Pharmacy medicine. MA Number: PL 20011/0039 (Moviprep); PL 20011/0006 (Moviprep Orange). MA Holder: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK. IRELAND Price and pack sizes: Lemon- or orange-flavoured powder in sachets, 1 treatment pack (2 x sachet A + 2 x sachet B) €13.26. Legal category: Product subject to medical prescription which may be renewed. MA Number: PA 1336/001/001 (Moviprep); PA 1336/001/002 (Moviprep Orange). MA Holder: Norgine BV, Antonio Vivaldistraat 150, 1083 HP Amsterdam, 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, UB9 6NS, UK. Tel: +44(0)1895 826606. Email: medinfo@norgine.com Date of preparation: June 2019. Company reference: UK/MPR/0619/0193.

limit their intake of cholesterol and eggs.

25


NEWS coeliac disease may have ongoing symptoms

Rare Disease Collaborative Network for non-responsive and refractory coeliac disease By Dr Heidi Urwin Coeliac UK Research Manager. Do you have patients diagnosed with coeliac disease who have ongoing symptoms despite a gluten free diet? Specialist teams led by Prof David Sanders in Sheffield and Dr Jeremy Woodward in Cambridge, have been approved by the NHS for a Rare Disease Collaborative Network (RDCN) to provide support with the diagnosis and care of those difficult cases of non responsive (NRCD) or refractory coeliac disease (RCD). The RDCN will provide facilities for a national registry for patients with refractory coeliac

and or laboratory abnormalities, despite six to 12 months treatment with a gluten free diet. When NRCD is suspected the original diagnosis of coeliac disease needs to be confirmed, followed by repeat gastroscopy with duodenal biopsies. Adherence to a gluten free diet varies from 42 to 91% and the most common cause of ongoing symptoms will be due to gluten exposure (inadvertent or purposeful). Other causes of ongoing symptoms may be due to “super sensitivity”, slow response to treatment, or other pathologies eg microscopic colitis, pancreatic insufficiency, Giardiasis, hyperthyroidism. Patients may broadly fit into one of four groups depending on the absence or presence of persisting symptoms and villous atrophy:

disease, a reference diagnostic pathway and

Normal duodenal Persisting villous histology atrophy

will share experience to improve understanding and management of this condition. For the majority of people diagnosed with

Persisting symptoms

Group 1

Group 2

No symptoms

Group 3

Group 4

coeliac disease, lifelong adherence to a strict gluten free diet results in clinical and histological remission. However, up to 30% of people with

GASTROENTEROLOGY TODAY - AUTUMN 2019

26

• Group 1, consider other causes of ongoing symptoms such as functional disorders, small intestinal bacterial overgrowth (SIBO), fructose or lactose intolerance. • Group 2, having excluded ongoing exposure to gluten, super sensitivity or a slow response to treatment, consider RCD. • Group 3, discharge to primary care and offer annual review in line with NICE NG20. • Group 4, discuss and explain ongoing inflammation and the potential risk of long term complications, consider further dietetic support. Refractory coeliac disease is rare and reported to affect between 0.3 to 4.0% of patients with coeliac disease. It’s also likely to be over diagnosed due to the difficulties in differentiating between ongoing gluten exposure, “super sensitivity”, slow responders and true RCD. There are two types of RCD, type 1 and type 2, which differ in presentation, diagnosis and mortality. Detailed analysis of cell populations in the duodenal mucosa using immunohistochemistry and flow cytometric analysis is required on fresh biopsy samples, services which are offered via the specialist centres in Cambridge and Sheffield.


NEWS Patients with RCD type 2 have an aberrant population of intestinal intraepithelial lymphocytes (IELs) that lack the usual expression of CD3 and CD8 on the cell surface but do express intracellular CD3. The phenotype of this IEL subset is present in the healthy population, uncomplicated coeliac disease and RCD type 1, but at lower frequencies to that found in RCD type 2. Therefore, clonality testing alone is not an adequate indicator of RCD type 2, which requires quantification of the aberrant IEL subset within the small intestine.

What is the NHS England’s Rare Diseases Collaborative Network (or RDCN) for (Non-Responsive and) Refractory Coeliac Disease?

Admissions for girls aged just 10 years old

a five year survival of around 50%, largely

have increased by 146%, from 13 in 2013/14

accounted for by progression to enteropathy

to 32 last year and for 12 year old girls,

associated T-cell lymphoma (EATL) in 33%

by 93% (from 60 to 116 in the same time

– 67% of cases. In contrast, while RCD type

period).

1 can progress to EATL, this is rare and the corresponding five year survival is > 90%.

The report states that although bulimia is

Transformation to EATL carries a very poor

more common among children and young

prognosis with the majority dying within 8

people, it is anorexia which accounts for the

months of diagnosis and a five year survival of

larger proportion of hospital admissions,

only around 10%.

fueling concern from leading addiction treatment experts at UKAT.

Clinicians who suspect they have any cases of refractory coeliac disease can visit the

“Eating disorders in young people and

Coeliac UK website for further information

children in particular is extremely concerning

www.coeliac.org.uk/RCD and contact david.

because they’re more likely to develop

sanders@sth.nhs.uk or Jeremy.woodward@

extensive physical and psychiatric problems

addenbrookes.nhs.uk

in the long term as a result of their eating disorder” suggests UKAT’s Group Treatment

Reference:

Lead, Nuno Albuquerque, who has vast

Baggus EMR, Hadjivassiliou M, Cross S et

experience of treating eating disorders.

al. How to manage adult coeliac disease: perspective from the NHS England Rare

He continues; “Unlike most other addictions

Diseases Collaborative Network for Non-

and disorders, the treatment cannot centre

Responsive and Refractory Coeliac Disease.

around abstinence, because we need to

Frontline Gastroenterology 2019; 0: 1-8. doi

eat to live. Instead treatment is focused on

10.1136/flgastro-2019-101191

finding a balance in the relationship between the person and food. For most, overcoming

Record breaking number of children hospitalised for eating disorders

eating disorders developed at such a young

Highest number of girls age 13-17

UKAT has also revealed that last year, they

admitted for anorexia as experts warn

admitted more people for eating disorders

parents of social media and celebrity

than ever before, and that this year, they’re

idolisation

taking on average around 5 enquiries a day

age is an ongoing process, and for some, will be something they live with- under controlled behaviours learned from treatment- forever.”

from concerned parents; double what they Public Health England has released its

were receiving last year. They run a specialist

report showing the trends in numbers of

eating disorder treatment facility called

hospital admissions as a result of eating

Banbury Lodge (www.banburylodge.com) in

disorders in young people across England,

Oxfordshire.

revealing that there were more admissions in 2017/18 than in any of the preceding

Public Health England’s report also raises

years.

concern about hospital admissions in young boys, showing that back in 2013/14, only 1

There were 2,196 hospital admissions

10 year old boy was admitted to hospital but

for eating disorder of children and young

in 2017/18, there were 9 and for 14 year old

people aged 10 to 24 years in 2017/18.

boys, 14 were admitted in 2013/14 which has

2,006 - an overwhelming 91%- of these

risen by 178% to 39 in 2017/18.

were of girls, and 1,326 of these were of girls aged 13 to 17 years.

Nuno concludes; “We believe that social media and celebrity idolisation has a lot to

The report breaks the number of hospital

do with the rise in eating disorders stemming

admissions down by specific age and

from body image issues, but there’s also

gender, and shows that across all ages,

a much deeper societal issue with children

more girls are admitted to hospital than

experiencing the deficit of attachment from

boys.

parents.”

GASTROENTEROLOGY TODAY - AUTUMN 2019

Sheffield and Cambridge have been approved as NHS England’s Rare Diseases Collaborative Network (or RDCN) for (Non-Responsive and) Refractory Coeliac Disease. NHS England has also recognised Sheffield as the lead centre and Cambridge as the member centre for this NHS E collaborative disease network. Clinicians who have cases of suspected refractory coeliac disease can contact david.sanders@sth.nhs.uk or Jeremy. woodward@addenbrookes.nhs.uk. These two centres will provide clinical support at the level that the referring clinician would wish. This can be by reviewing notes, histological review, telephone consultation (with patient or clinician) or by seeing the patient and assessing small bowel biopsy for monoclonal lymphocyte population, as well as endoscopic intervention (capsule endoscopy or enteroscopy). This ensures a comprehensive assessment which then leads to discussions about therapeutic options. Therapeutic intervention can again be provided by the RDCN or the referring site. The most important issue is to ensure that patients have a standardised care and that the RDCN can support colleagues in a collaborative manner. The RDCN will also create a National Register to provide prospective data on such patients, analogous to Small Bowel Transplantation. This may allow consideration for novel treatments such as Interleukin-15 or stem cell transplantation

The prognosis of RCD type 2 is poor with

27


POSTERS

COLITIS ON CT – DOES THIS MEAN

Ramakrishnan S, Veglio-Taylor E, Ta Department of Gastroenterology, Barnet Hospital, Royal Fre

BACKGROUND: Cross sectional imaging is commonly used to assess the abdomen for a variety of symptoms. Colitis reported on CT has become a frequent indication for lower gastrointestinal endoscopy. The outcomes of performing colonoscopy for radiology reported colitis is not clearly known. METHODS: Retrospective single centre study of patients referred for colonoscopy with the indication ‘abnormal imaging.’ Data collected from all endoscopies between 12 month period at Barnet General Hospital (September 2017 to August 2018). Exclusion criteria: 1) Modality other than CT/CTVC 2) Overt colonic polyp/mass on CT Analysis performed using chi-square and student T-test.

Median time from CT to endoscop 56.5).

53 (21.3%) patients of the 249 wh had completely normal lower GI en uncomplicated diverticulosis, 11 (8.0%) haemorrhoids and 37 (14.9%

20 patients (8.0%) had endoscop (6%) histological evidence of coliti 10 patients (4%) had confirmed I (4 Ulcerative colitis, 6 Crohn’s dise

Fig.2 - Reported CT findings as indic 200 150 100 50

i

m m at

L

In fla

nd in g

Fa tS tra

al T

hi ck

en in g

0

M ur

GASTROENTEROLOGY TODAY - AUTUMN 2019

250

NUMBER OF PATIENTS

Fig.1 – Radiological evidence of colitis

RESULTS: 249 patients (183 CT (73.5%), 66 C colonoscopy for CT evidence o (87.6%)), fat stranding (88 (35. (41.8%)) or local lymph nodes (37 (

28

CT FINDING


POSTERS

INFLAMMATORY BOWEL DISEASE?

ariq Z, King J, Patel RN, Besherdas K. ee London NHS Foundation Trust, London, United Kingdom.

CTVC (26.5%)) underwent a of mural thickening (218 .3%)), inflammation (104 (14.9%)).

py was 33 days (IQR 12.5 –

ho underwent investigation ndoscopy. 111 (44.6%) had 1 (4.4%) diverticulitis, 20 %) colorectal polyps.

pic evidence of colitis; 14 is. IBD at 6 months follow up ease).

No de s

ym ph

Lo ca lL

G

Normal (n=53)

Colitis (n=20)

Malignancy (n=21)

*p value

54.4

69.5

<0.02

24.5

24.9

<0.04

Mural thickening (%) 48 (90.1)

19 (95)

20 (95.2)

ns

Fat stranding (%) 14 (26.4)

12 (60)

9 (42.9)

<0.03

Inflammation (%) 16 (30.2)

12 (60)

9 (42.9)

0.06

Lymph nodes (%) 4 (5.7)

8 (40)

11 (52.4)

<0.00006

123.8

112.2

0.005

55.5

68.1

0.10, <0.05

Age, mean 63.6 Time to endoscopy (days), mean 45.3

Haemoglobin (g/L), mean 128.0 CRP (mg/L), mean 29.8

CONCLUSIONS: • Colitis reported on CT correlates with endoscopic colitis in only 8% of patients. • Less than 5% of patients with colitis on CT are diagnosed with IBD at 6 months. • Correlation between colitis and endoscopic findings improves in younger patients and with shorter interval between CT and endoscopy. • One in five patients had completely normal endoscopy. 90% had a benign diagnosis. • Fat stranding was an independent risk factor for endoscopic colitis. • Anaemia and raised CRP helps identify those at higher risk of malignancy. • Raised CRP shows a trend toward identifying true colitis.

GASTROENTEROLOGY TODAY - AUTUMN 2019

io n

cation for Colonoscopy

Fig.3 - Comparison of endoscopic diagnosis according to CT features and blood results

The findings of ’Colitis’ on CT does not imply IBD in the majority.

29


COMPANY NEWS

CANTEL CANEXIS™ INTEGRATED WORKFLOW SOLUTION & LYNGSOE SYSTEMS X-TRACKING™ WORKING IN PARTNERSHIP AT NHS LOTHIAN Cantel and Lyngsoe Systems are pleased to announce they have won a 7-year contract to supply NHS Lothian with new cutting-edge software to help manage and track sterile assets across the Health Board.

experts within their fields and this combined solution helps the Health Board manage their inventory of surgical instruments to ensure full traceability and safety throughout the sterilisation and decontamination processes. The ever-rising quantity of instruments and the increasing variation of maintenance and sterilization procedures have made

Cantel will be supplying their new CANEXIS™ Integrated Workflow

the “traceability” issue one of the major topics in hospital quality

Solution which links data and decision-making to support the efficient

management.

operation of your critical hospital departments. The fully integrated solution brings together differing departmental software into one

Integration of these two software systems will provide full visibility

powerful tool and is available for Endoscopy, Sterilisation & Surgical

of tray sets, endoscopes and other sterile goods as they leave the

departments. The system will launch within the sterile processing

sterilisation and decontamination departments and record them arriving

department at the Royal Infirmary Edinburgh and extend out to

at the remote storage facilities spread across the Health Board.

endoscopy, dental and local decontamination units and operating theatres throughout the Health Board. Lyngsoe Systems will be

The X-Tracking™ software will also be used to help keep track of

supplying the X-TRACKING™ Location Tracking Software which will

the health boards large inventory of medical devices. The clinical

track and trace the RFID tagged surgical sets, endoscopes and

engineering team have already started deploying new RFID embedded

equipment kits as they move between the different hospitals and

GS1 asset labels to their medical devices and will be integrating the

storage facilities.

X-Tracking™ software with their Medusa asset management software.

This project will be the first of its kind in Scotland to deliver a fully

About Lyngsoe Systems:

integrated solution with GS1 Standards and provides NHS Lothian with

Lyngsoe Systems has been a world leader in the field of cutting-edge

a powerful tool to maximise operational efficiency whilst maintaining

electronic logistics control for over 40 years and is leading within

high standards of patient safety. Cantel and Lyngsoe Systems are both

the radio frequency identification (RFID) technology. With a proven record of accomplishment of more than 5000 installations in 60 countries, the Lyngsoe Systems team can demonstrate extensive experience in customer process knowledge, solution design, software development, integration, service and maintenance. About Cantel: Cantel deliver a comprehensive range of infection prevention products and services. Starting with

GASTROENTEROLOGY TODAY - AUTUMN 2019

the solution you need most, from Procedure, Manual Clean, Reprocess, Dry & Store solutions, and Track & Traceability software, they help you remove risk and streamline operational efficiencies to optimise your success. Cantel provides high-quality infection prevention solutions and unsurpassed service, touching millions of patients around the world each year. Contact Lyngsoe Systems at: Phone: +44 20 3630 1602 Email: healthcare@lyngsoesystems. comhealthcare@lyngsoesystems.com Contact Cantel at: Phone: +44 1702 291878 Email: info@cantelmedical.co.uk

30


COMPANY NEWS

GASTROENTEROLOGY TODAY - AUTUMN 2019

31


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

Profile for Media Publishing Company

Gastroenterology Today - Autumn 2019  

Gastroenterology Today - Autumn 2019