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ERCP

ERCP

Third Edition

Todd H. Baron, MD, FASGE

Professor of Medicine

Division of Gastroenterology and Hepatology

University of North Carolina School of Medicine

Chapel Hill, North Carolina

Richard A. Kozarek, MD, FASGE

Executive Director

Digestive Disease Institute

Department of Gastroenterology

Virginia Mason Medical Center

Seattle, Washington

David L. Carr-Locke, MD, FRCP, FASGE, FACG

Clinical Director

Center for Advanced Digestive Care

Division of Gastroenterology and Hepatology

Weill Cornell Medicine

Cornell University

New York, New York

1600 John F. Kennedy Blvd.

Ste 1800 Philadelphia, PA 19103-2899

ERCP: THIRD EDITION

Copyright © 2019 by Elsevier, Inc. All rights reserved.

ISBN: 978-0-323-48109-0

No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the Publisher. Details on how to seek permission, further information about the Publisher’s permissions policies, and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency can be found at our website: www.elsevier.com/permissions

This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein).

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods, they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

With respect to any drug or pharmaceutical products identified, readers are advised to check the most current information provided (i) on procedures featured or (ii) by the manufacturer of each product to be administered, to verify the recommended dose or formula, the method and duration of administration, and contraindications. It is the responsibility of practitioners, relying on their own experience and knowledge of their patients, to make diagnoses, to determine dosages and the best treatment for each individual patient, and to take all appropriate safety precautions.

To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence, or otherwise or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

Previous editions copyrighted 2013 and 2008.

ISBN: 978-0-323-48109-0

Content Strategist: Nancy Anastasi Duffy

Senior Content Development Specialist: Ann Anderson

Publishing Services Manager: Catherine Albright Jackson

Senior Project Manager: Doug Turner

Designer: Brian Salisbury

The third edition of ERCP is dedicated to our patients… as well as to our families, who have endured our long days at work only to watch in exasperation as we spent our evenings and weekends finessing verbiage, adding images and references, and cajoling tardy chapter authors: it’s finally your turn!

At least until we plan the fourth edition.

CONTRIBUTORS

Douglas G. Adler, MD, FACG, AGAF, FASGE

Professor of Medicine

Director of Therapeutic Endoscopy

Director of GI Fellowship Program

Gastroenterology and Hepatology

University of Utah School of Medicine

Huntsman Cancer Center

Salt Lake City, Utah

Sushil K. Ahlawat, MD, FACP, FASGE, AGAF

Associate Professor of Medicine

Director of Endoscopy

Program Director, Gastroenterology and Hepatology Fellowship

Program Director, Advanced Endoscopy Fellowship

Division of Gastroenterology and Hepatology

Rutgers New Jersey Medical School

Newark, New Jersey

Jawad Ahmad, MD, FRCP, FAASLD

Professor of Medicine

Division of Liver Diseases

Icahn School of Medicine at Mount Sinai

New York, New York

Firas H. Al-Kawas, MD

Professor of Medicine

Division of Gastroenterology and Hepatology

Johns Hopkins University

Baltimore, Maryland

Director of Johns Hopkins Endoscopy Program

Sibley Memorial Hospital

Washington, District of Columbia

Michelle A. Anderson, MD

Associate Professor of Medicine

Taubman Center

University of Michigan

Ann Arbor, Michigan

Everson Luiz de Almeida Artifon, MD, PhD, FASGE

Coordinator of Pancreatic Biliary Endoscopy Unit

GI Endoscopy Service

Hospital de Clinicas of the University of Sao Paulo

Associate Professor of Surgery

University of Sao Paulo

Sao Paulo, Brazil

João Guilherme Guerra de Andrade

Lima Cabral, MD

Endoscopist

Advanced Endoscopy Unit

A.C. Camargo Cancer Center

São Paulo, Brazil

John Baillie, MD

Professor of Medicine

Chief of Endoscopy

Virginia Commonwealth University School of Medicine

Richmond, Virginia

Rupa Banerjee, MD, DTM

Consultant

Gastroenterologist

Asian Institute of Gastroenterology

Hyderabad, India

Todd H. Baron, MD, FASGE

Professor of Medicine

Division of Gastroenterology and Hepatology

University of North Carolina School of Medicine

Chapel Hill, North Carolina

Omer Basar, MD

Gastrointestinal Unit

Pancreas Biliary Center

Massachusetts General Hospital

Boston, Massachusetts

Professor of Medicine

Department of Gastroenterology

Hacettepe University Medical School

Ankara, Turkey

Petros C. Benias, MD

Director of Endoscopic Surgery

Division of Gastroenterology

Northwell Health System

Hofstra Zucker School of Medicine

Manhasset, New York

Ivo Boškoski, MD, PhD

Digestive Endoscopy Unit

Cattolic University of Rome

Rome, Italy

Michael J. Bourke, MBBS, FRACP

Clinical Professor of Medicine

Director of Endoscopy

Gastroenterology and Hepatology

Westmead Hospital

Sydney, Australia

Brian C. Brauer, MD

Associate Professor of Medicine

University of Colorado School of Medicine

Aurora, Colorado

William R. Brugge, MD

Professor of Medicine

Harvard Medical School

Director of Gastrointestinal Unit

Pancreas Biliary Center

Massachusetts General Hospital

Boston, Massachusetts

Jonathan M. Buscaglia, MD

Associate Professor and Division Chief

Gastroenterology and Hepatology

Stony Brook University School of Medicine

Stony Brook, New York

David L. Carr-Locke, MD, FRCP, FASGE, FACG

Clinical Director

Center for Advanced Digestive Care

Division of Gastroenterology and Hepatology

Weill Cornell Medicine

Cornell University

New York, New York

Prabhleen Chahal, MD

Physician

Department of Gastroenterology and Hepatology

Cleveland Clinic

Cleveland, Ohio

Sujievvan Chandran, MBBS, FRACP

Therapeutic Endoscopy Fellow

Gastroenterology

St. Michaels’s Hospital

Toronto, Ontario, Canada

Yen-I Chen, MD

Assistant Professor of Medicine

Division of Gastroenterology and Hepatology

McGill University Health Center

Montreal, Quebec, Canada

Anthony J. Choi, MD

Resident Physician

Department of Medicine

Weill Cornell Medicine

Cornell University

New York, New York

Jonah Cohen, MD

Clinical Fellow in Advanced Endoscopy

Division of Gastroenterology

Beth Israel Deaconess Medical Center

Boston, Massachusetts

Guido Costamagna, MD, FACG

Digestive Endoscopy Unit

Catholic University

Gemelli University Hospital

Rome, Italy

Chair of Digestive Endoscopy

USIAS Strasbourg University Strasbourg, France

Gregory A. Coté, MD

Associate Professor of Medicine

Division of Gastroenterology and Hepatology

Department of Medicine

Medical University of South Carolina Charleston, South Carolina

Peter Cotton, MD, FRCS, FRCP

Professor of Medicine

Digestive Disease Center

Medical University of South Carolina Charleston, South Carolina

Koushik K. Das, MD

Assistant Professor of Medicine Division of Gastroenterology

Washington University School of Medicine St. Louis, Missouri

Jacques Devière, MD, PhD

Professor of Medicine

Head

Department of Gastroenterology, Hepatology, and Digestive Oncology

CUB Erasme

Université Libre de Bruxelles Brussels, Belgium

Steven A. Edmundowicz, MD

Professor of Medicine

University of Colorado School of Medicine Aurora, Colorado

Ihab I. El Hajj, MD, MPH

Assistant Professor of Medicine

Division of Gastroenterology and Hepatology

Indiana University Indianapolis, Indiana

Douglas O. Faigel, MD, FACG, FASGE, AGAF

Professor of Medicine

Department of Gastroenterology and Hepatology

Mayo Clinic Scottsdale, Arizona

Pietro Familiari, MD, PhD

Fondazione Policlinico Gemelli

Digestive Endoscopy Unit

Rome, Italy

Paul Fockens, MD, PhD, FASGE

Professor and Chair

Gastroenterology and Hepatology

Academic Medical Center Amsterdam, Netherland

Evan L. Fogel, MD

Professor of Medicine

Division of Gastroenterology and Hepatology

Indiana University School of Medicine Indianapolis, Indiana

Victor L. Fox, MD

Associate Professor of Pediatrics

Harvard Medical School

Director of GI Procedure and Endoscopy Unit

Division of Gastroenterology, Hepatology, and Nutrition

Boston Children’s Hospital Boston, Massachusetts

Martin L. Freeman, MD Professor of Medicine

Division of Gastroenterology, Hepatology, and Nutrition

University of Minnesota Minneapolis, Minnesota

S. Ian Gan, MD

Department of Gastroenterology

Virginia Mason Medical Center Seattle, Washington

Andres Gelrud, MD, MMSc, FASGE

Director

Pancreatic Disease Center

Miami Cancer Institute Miami, Florida

Gregory G. Ginsberg, MD

Professor of Medicine

Department of Medicine

Division of Gastroenterology

Hospital of the University of Pennsylvania Philadelphia, Pennsylvania

Michael Gluck, MD

Past Chief of Medicine

Department of Gastroenterology

Virginia Mason Medical Center

Seattle, Washington

Khean-Lee Goh, MBBS, FRCP, MD Professor

Gastroenterology and Medicine

University of Malaya

Kuala Lumpur, Malaysia

Robert H. Hawes

Professor of Medicine

University of Central Florida College of Medicine

Medical Director

Florida Hospital Institute for Minimally Invasive Therapy

Center for Interventional Endoscopy

Florida Hospital Orlando Orlando, Florida

Jennifer T. Higa, MD

Advanced Endoscopy Fellow

Department of Gastroenterology

Virginia Mason Medical Center Seattle, Washington

Jordan D. Holmes, MD

Gastroenterologist

Iowa Digestive Disease Center Clive, Iowa

Shayan Irani, MBBS, MD

Department of Gastroenterology

Virginia Mason Medical Center Seattle, Washington

Takao Itoi, MD, PhD, FASGE, FACG Professor and Chair

Department of Gastroenterology and Hepatology

Tokyo Medical University

Tokyo, Japan

Priya A. Jamidar, MD Professor of Medicine

Director of Endoscopy

Section of Digestive Diseases

Yale University

New Haven, Connecticut

Michel Kahaleh, MD

Professor of Medicine

Division of Gastroenterology and Hepatology

Department of Medicine

Weill Cornell Medicine

Cornell University

New York, New York

Anthony N. Kalloo, MD

The Moses and Helen Golden Paulson Professor of Gastroenterology

Director of Division of Gastroenterology and Hepatology

The Johns Hopkins Hospital Baltimore, Maryland

Mouen A. Khashab, MD

Director of Therapeutic Endoscopy

Associate Professor of Medicine

Department of Gastroenterology and Hepatology

The Johns Hopkins Hospital Baltimore, Maryland

Michael L. Kochman, MD

Wilmott Family Professor of Medicine

Division of Gastroenterology

Department of Medicine

Perelman School of Medicine

University of Pennsylvania Philadelphia, Pennsylvania

Tadashi Kodama, MD, PhD

Advisor

Department of Gastroenterology

Iwasaki Hospital

Mitoyo City, Kagawa, Japan

Andrew Korman, MD

Division of Gastroenterology and Hepatology

Saint Peter’s University Hospital New Brunswick, New Jersey

Paul Kortan, MD, FRCPC, FASGE, AGAF

Department of Medicine

St. Michael’s Hospital University of Toronto Toronto, Ontario, Canada

Tatsuya Koshitani, MD, PhD

Director of Department of Gastroenterology

Japan Community Healthcare Organization

Kobe Central Hospital Kobe City, Hyogo, Japan

Richard A. Kozarek, MD, FASGE

Executive Director

Digestive Disease Institute

Department of Gastroenterology

Virginia Mason Medical Center

Seattle, Washington

Michael Larsen, MD

Gastroenterologist

Digestive Disease Institute

Virginia Mason Medical Center

Seattle, Washington

James Y.W. Lau, MD

Chairman and Yao Ling Sun Professor of Surgery

The Chinese University of Hong Kong

Shatin, Hong Kong, China

Ryan Law, DO

Clinical Lecturer

Division of Gastroenterology

University of Michigan

Ann Arbor, Michigan

Glen Lehman, MD

Professor of Medicine

Division of Gastroenterology

Department of Medicine

Indiana University

Indianapolis, Indiana

Joseph W. Leung, MD, FRCP, FACP, MACG, FASGE

Mr. and Mrs. C.W. Law Professor of Medicine

Division of Gastroenterology and Hepatology

University of California Davis School of Medicine

Sacramento, California

Section Chief of Gastroenterology

Veterans Affairs Northern California Health Care System

Mather, California

Dario Ligresti, MD

Endoscopy Service

Department of Diagnostic and Therapeutic Services

IRCCS ISMETT (Instituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)

Palermo, Italy

Eugene Lin, MD

Attending Radiologist

Virginia Mason Medical Center

Seattle, Washington

Simon K. Lo, MD, FACP

Director of Endoscopy

Head of Pancreatic Diseases Program

Division of Digestive Diseases and Hepatology

Cedars-Sinai Medical Center

Clinical Professor of Medicine

David Geffen School of Medicine at UCLA

Los Angeles, California

Michael X. Ma, MBBS, FRACP

Advanced Endoscopy Fellow

Gastroenterology and Hepatology

Westmead Hospital

Sydney, Australia

John T. Maple, DO

Associate Professor of Medicine

Division of Digestive Diseases and Nutrition

University of Oklahoma

Oklahoma City, Oklahoma

Alberto Mariani, MD

Pancreato-Biliary Endoscopy and Endosonography Division

Pancreas Translational and Clinical Research Center

San Raffaele Scientific Institute

Vita Salute San Raffaele University

Via Olgettina

Milan, Italy

Gary May, MD, FRCPC, FASGE

Division of Gastroenterology

Department of Medicine

The Center of Advanced Therapeutic Endoscopy and Endoscopic Oncology

St. Michael’s Hospital

University of Toronto Faculty of Medicine

Toronto, Ontario, Canada

Lee McHenry, MD

Professor of Medicine

Division of Gastroenterology

Department of Medicine

Indiana University

Indianapolis, Indiana

Meir Mizrahi, MD

Director of Advanced Endoscopy

Internal Medicine

Division of Gastroenterology

University of South Alabama College of Medicine

Mobile, Alabama

Rawad Mounzer, MD

Assistant Professor of Medicine

Digestive Institute

Banner-University Medical Center

University of Arizona

Phoenix, Arizona

Thiruvengadam Muniraj, MD, PhD, MRCP(UK)

Assistant Professor of Medicine

Director of Yale Center for Pancreatitis

Section of Digestive Diseases

Yale University School of Medicine

New Haven, Connecticut

Horst Neuhaus, MD

Professor of Medicine

Chief of the Department of Internal Medicine

Evangelisches Krankenhaus Düsseldorf Düsseldorf, Germany

Ian D. Norton, MBBS, PhD

Associate Professor Department of Gastroenterology

Royal North Shore Hospital Sydney, Australia

Manuel Perez-Miranda, MD, PhD

Head of Gastroenterology and Hepatology

Hospital Universitario Rio Hortega

Associate Professor of Medicine

Valladolid University Medical School Valladolid, Spain

Bret T. Petersen, MD Professor of Medicine

Department of Gastroenterology and Hepatology

Mayo Clinic Rochester, Minnesota

Douglas Pleskow, MD

Associate Clinical Professor Department of Medicine

Harvard Medical School

Chief of Clinical Gastroenterology

Beth Israel Deaconess Medical Center

Boston, Massachusetts

Tugrul Purnak, MD

Associate Professor of Medicine Gastroenterology and Hepatology

Hacettepe University Medical School Ankara, Turkey

G. Venkat Rao, MS, MAMS, FRCS

Director and Chief of Gastrointestinal and Minimally Invasive Surgery

Asian Institute of Gastroenterology Hyderabad, India

Anthony Razzak, MD Gastroenterologist

Oregon Clinic

Portland, Oregon

D. Nageshwar Reddy, MBBS, MD, DM Director and Chief Gastroenterologist

Asian Institute of Gastroenterology Hyderabad, India

Andrew S. Ross, MD

Section Head of Gastroenterology

Medical Director

Therapeutic Endoscopy Center of Excellence

Virginia Mason Medical Center

Seattle, Washington

Alexander M. Sarkisian, MD

Resident Physician

Internal Medicine

Tulane University School of Medicine

New Orleans, Louisiana

Beth Schueler, PhD

Professor of Medical Physics

Department of Radiology

Mayo Clinic

Rochester, Minnesota

Dong Wan Seo, MD, PhD

Professor Gastroenterology

University of Ulsan College of Medicine

Asan Medical Center

Seoul, South Korea

Raj J. Shah, MD, FASGE, AGAF

Professor of Medicine

Division of Gastroenterology

University of Colorado School of Medicine

Director of Pancreaticobiliary Endoscopy

Division of Gastroenterology

University of Colorado Anschutz Medical Campus

Aurora, Colorado

Reem Z. Sharaiha, MD, MSc

Assistant Professor of Medicine

Division of Gastroenterology and Hepatology

Weill Cornell Medicine

Cornell University

New York City, New York

Stuart Sherman, MD

Professor of Medicine and Radiology

Glen Lehman Professor in Gastroenterology

Division of Gastroenterology and Hepatology

Indiana University

Indianapolis, Indiana

Chan Sup Shim, MD, PhD, FASGE, AGAF

Professor

Department of Gastroenterology

Kunkuk University Medical Center

Seoul, South Korea

Ajaypal Singh, MD

Director of Advanced Endoscopy

Rush University Medical Center

Chicago, Illinois

Adam Slivka, MD, PhD

Professor of Medicine

Associate Chief of Clinical Services

Division of Gastroenterology, Hepatology, and Nutrition

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania

Sanjeev Solomon, MD

Howard University Hospital

Washington, District of Columbia

Tae Jun Song, MD, PhD

Associate Professor

Gastroenterology

University of Ulsan College of Medicine

Asan Medical Center

Seoul, South Korea

Indu Srinivasan, MD

Advanced Endoscopy Fellow

Maricopa Integrated Health System Chandler, Arizona

Joseph J.Y. Sung, MD, PhD

President and Vice Chancellor

Mok Hing Yiu Professor of Medicine

The Chinese University of Hong Kong

Shatin, Hong Kong, China

Ilaria Tarantino, MD

Endoscopy Service

Department of Diagnostic and Therapeutic Services

IRCCS ISMETT (Instituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione)

Palermo, Italy

Paul R. Tarnasky, MD

Physician

Methodist Dallas Medical Center

Dallas, Texas

Pier Alberto Testoni, MD, FASGE

Director of Division of Gastroenterology and GI Endoscopy

San Raffaele Scientific Institute

Vita Salute San Raffaele University

Via Olgettina

Milan, Italy

Catherine D. Tobin, MD

Associate Professor of Anesthesiology

Department of Anesthesia

Medical University of South Carolina

Charleston, South Carolina

Mark Topazian, MD

Professor of Medicine

Department of Gastroenterology and Hepatology

Mayo Clinic Rochester, Minnesota

Sachin Wani, MD

Associate Professor of Medicine

Division of Gastroenterology and Hepatology

University of Colorado Anschutz Medical Campus Aurora, Colorado

John C.T. Wong, MD

Clinical Professional Consultant

Institute of Digestive Disease

The Chinese University of Hong Kong

Shatin, Hong Kong, China

Andrew W. Yen, MD, MAS, FACG, FASGE

Associate Chief of Gastroenterology

Veterans Affairs Northern California Health Care System

Mather, California

Assistant Clinical Professor of Medicine

Division of Gastroenterology and Hepatology

University of California Davis School of Medicine

Sacramento, California

What a difference 10 years makes. Since the first edition of ERCP published in 2008, it seems like there has been a cosmic shift in the practice of gastrointestinal medicine and endoscopy. Diagnostic ERCP has given way to continued improvements in computed tomography and magnetic resonance imaging, as well as to endoscopic ultrasound (EUS), which provides information not only about the diameter, contents, and contours of the pancreaticobiliary ducts but also about the pancreatic and liver parenchyma, contiguous organs, relevant vasculature, and lymph nodes. Additionally, EUS has been shown to have improved sensitivity for the diagnosis of pancreatic malignancy compared with brushing or biopsy done at time of ERCP. Moreover, as technology and EUS experience have expanded, therapeutic procedures previously relegated to ERCP (or interventional radiology) are increasingly being done with an echoendoscope: gallbladder and bile duct access for cholecystoduodenal, hepatobiliary, and choledochoduodenal stenting; endoscopic anastomosis of obstructed afferent limbs; gastroenterostomy for bypass of malignant duodenal obstruction; PD imaging and duct decompression in difficultto-access anatomy; and imaging and treatment of pancreatic fluid collections, many of which were previously imaged and variably treated with ERCP. The barbarians are at the gate!

Or are they? ERCP with sphincterotomy and/or balloon dilation remains the treatment of choice for choledocholithiasis and for many cases of pancreatic stones. Moreover, it maintains primacy for the treatment of benign pancreaticobiliary strictures and most malignancies causing obstructive jaundice. In contrast, therapeutic EUS has evolved to allow access in complex postoperative anatomy, duodenal obstruction, or after failed ERCP. In fact, we are the barbarians who often employ both echoendoscopes and duodenoscopes in the same patient under a single anesthesia to stage a patient with malignant obstructive jaundice, obtain a definitive tissue diagnosis, and render appropriate palliative

therapy. Alternatively, we may use EUS to access the pancreaticobiliary tree as part of a rendezvous procedure to improve the success rate of ERCP. The third edition of this text acknowledges the expanded role that EUS has come to play in patients previously undergoing diagnostic or therapeutic ERCP alone. Utilizing one procedure without access to the other is a disservice to our patients and encourages the overuse of one of the (potentially) more dangerous therapeutic endoscopic procedures we perform.

What a difference 10 years makes. Look for the new chapters, including one on endoscope disinfection. This should not come as a surprise to anyone as both the lay press and medical literature have been awash in cases of antibiotic resistant bacterial infections, which can be traced back to duodenoscopes contaminated with the same organism. What else is new in the third edition of ERCP? Almost everything: new images, updated videos, and multiple chapters that incorporate EUS and place it into the perspective of modern ERCP practice. However, there is much that has not changed in the current edition of this text. Most notably we have retained the world’s premier clinicians and endoscopic researchers to share their ERCP experience, their wisdom, and their cautions to us all.

ACKNOWLEDGMENT

The Editors thank our medical colleagues and support staff for their outstanding contributions to our patients’ care and the authors of this textbook for their new or updated contributions.

Todd H. Baron, MD, FASGE Richard A. Kozarek, MD, FASGE David L. Carr-Locke, MD, FRCP, FASGE, FACG

SECTION I General Topics

1. Approaching 50 Years: The History of ERCP, 1

Lee McHenry and Glen Lehman

2. The ERCP Room, 7

Brian C. Brauer and Steven A. Edmundowicz

3. Radiologic Issues and Radiation Safety During ERCP, 14

Eugene Lin and Beth Schueler

4. Endoscopes, Guidewires, and Accessories, 30

Sushil K. Ahlawat and Firas H. Al-Kawas

5. Duodenoscope Reprocessing, 44

Jennifer T. Higa, Michael Gluck, and Andrew S. Ross

6. Sedation in ERCP, 49

Catherine D. Tobin and Gregory A. Coté

7. Indications for and Contraindications to ERCP, 54

Sanjeev Solomon and John Baillie

8. Adverse Events of ERCP: Prediction, Prevention, and Management, 59

Indu Srinivasan and Martin L. Freeman

9. ERCP Training, 68

Rawad Mounzer and Sachin Wani

10. Preparation of the Patient for ERCP, 80

John T. Maple

11. Principles of Electrosurgery, 86

Petros C. Benias and David L. Carr-Locke

12. Quality Issues and Measures in ERCP, 93

Jordan D. Holmes and Douglas O. Faigel

13. Medicolegal Issues in ERCP, 99

Peter Cotton

SECTION II Techniques

14. Cannulation of the Major Papilla, 108

Michael J. Bourke and Michael X. Ma

15. Access (Precut) Papillotomy, 123

Sujievvan Chandran, Gary May, and Paul Kortan

16. Sphincter of Oddi Manometry, 132

Tugrul Purnak and Evan L. Fogel

17. Biliary Sphincterotomy, 137

Horst Neuhaus

18. Balloon Dilation of the Native and Postsphincterotomy Papilla, 148

Chan Sup Shim

19. Stone Extraction, 160

Andrew W. Yen and Joseph W. Leung

20. Pancreatic Sphincterotomy, 171

Jonathan M. Buscaglia and Anthony N. Kalloo

21. Minor Papilla Cannulation and Sphincterotomy, 182

Pier Alberto Testoni and Alberto Mariani

22. Plastic Pancreaticobiliary Stents and Nasopancreaticobiliary Tubes: Concepts and Insertion Techniques, 196

Ryan Law and Todd H. Baron

23. Biliary Metal Stent Insertion: Indications and Insertion Techniques, 206

Koushik K. Das and Gregory G. Ginsberg

24. Pancreaticobiliary Stent Retrieval, 216

Anthony Razzak, Everson Luiz de Almeida Artifon, and Richard A. Kozarek

25. Papillectomy and Ampullectomy, 230

Shayan Irani and Richard A. Kozarek

26. Pancreatoscopy, 242

Tadashi Kodama and Tatsuya Koshitani

27. Cholangioscopy, 249

Raj J. Shah and Takao Itoi

28. Endomicroscopy in the Pancreaticobiliary Tree, 259

Anthony J. Choi and Michel Kahaleh

29. ERCP in Children, 263

Victor L. Fox

30. ERCP in Pregnancy, 282

Thiruvengadam Muniraj and Priya A. Jamidar

31. ERCP in Surgically Altered Anatomy, 288

Simon K. Lo

32. Endoscopic Ultrasonography–Guided Biliary Drainage, 308

Manuel Perez-Miranda

33. Endoscopic Ultrasound and EUS-Guided Endotherapy, 321 S. Ian Gan

SECTION III Approach to Clinical Problems

34. Pancreaticobiliary Disorders: What Are the Roles of CT, MRCP, and EUS Relative to ERCP?, 328

Andres Gelrud and Ajaypal Singh

35. Pancreas Divisum, Biliary Cysts, and Other Congenital Anomalies, 335

Mark Topazian

36. Dilated Bile Duct and Pneumobilia, 346

Koushik K. Das and Michael L. Kochman

37. The Dilated Pancreatic Duct, 354

Douglas G. Adler and Michelle A. Anderson

38. Ampullary Neoplasia, 361

Paul Fockens and Ian D. Norton

39. Malignant Biliary Obstruction: Distal, 372

Meir Mizrahi, Jonah Cohen, João Guilherme Guerra de Andrade

Lima Cabral, and Douglas Pleskow

40. Malignant Biliary Obstruction of the Hilum and Proximal Bile Ducts, 385

Alexander M. Sarkisian and Reem Z. Sharaiha

41. Indeterminate Biliary Stricture, 394

Bret T. Petersen

42. Endoscopic Approaches to Concomitant Malignant Biliary Obstruction and Gastric Outlet Obstruction, 405

Yen-I Chen, Todd H. Baron, and Mouen A. Khashab

43. Benign Biliary Strictures, 417

Guido Costamagna, Ivo Boškoski, and Pietro Familiari

44. Biliary Surgery Adverse Events, Including Liver Transplantation, 422

Ilaria Tarantino, Todd H. Baron, and Dario Ligresti

45. ERCP and EUS for Acute and Chronic Adverse Events of Pancreatic Surgery and Pancreatic Trauma, 432

Prabhleen Chahal and Todd H. Baron

46. Choledocholithiasis, 441

John C.T. Wong, James Y.W. Lau, and Joseph J.Y. Sung

47. Pancreaticobiliary Pain and Suspected Sphincter of Oddi Dysfunction, 449

Paul R. Tarnasky and Robert H. Hawes

48. Sclerosing Cholangitis, 457

Jawad Ahmad and Adam Slivka

49. Tropical Parasitic Infestations, 464

D. Nageshwar Reddy, G. Venkat Rao, and Rupa Banerjee

50. Recurrent Pyogenic Cholangitis, 469

Tae Jun Song, Dong Wan Seo, and Khean-Lee Goh

51. Cystic Lesions of the Pancreas, 480

Omer Basar and William R. Brugge

52. Unexplained Acute Pancreatitis and Acute Recurrent Pancreatitis, 486

Ihab I. El Hajj and Stuart Sherman

53. Biliary Intervention in Acute Gallstone Pancreatitis, 499

Andrew Korman and David L. Carr-Locke

54. Pancreatic Interventions in Acute Pancreatitis: Ascites, Fistulae, Leaks, and Other Disruptions, 506

Michael Larsen and Richard A. Kozarek

55. Chronic Pancreatitis: Stones and Strictures, 516

Jacques Devière, Todd H. Baron, and Richard A. Kozarek

56. Endoscopic Drainage of Pancreatic Pseudocysts, Abscesses, and Walled-Off (Organized) Necrosis, 525

Ryan Law and Todd H. Baron

Chapter 8 Adverse Events of ERCP: Prediction, Prevention, and Management

Video 8.1 Postsphincterotomy Oozing

Video 8.2 Postampullectomy Bleeding: Hemoclip

Video 8.3 Guidewire Perforation of the Bile Duct

Video 8.4 Retroperitoneal Perforation

Video 8.5 Retroperitoneal Perforation

Video 8.6 Retroperitoneal Sphincterotomy Perforation

Chapter 14 Cannulation of the Major Papilla

Video 14.1 Wire Lead Technique of Cannulation

Video 14.2 Wire Lead Technique of Cannulation

Video 14.3 Needle-Knife Sphincterotomy

Video 14.4 Needle-Knife Sphincterotomy

Video 14.5 Needle-Knife Sphincterotomy

Video 14.6 Pancreatic Cannulation

Chapter 15 Access (Precut) Papillotomy

Video 15.1 Fistulotomy in a Diverticulum

Video 15.2 Impacted Stone Fistulotomy

Chapter 16 Sphincter of Oddi Manometry

Video 16.1 Sphincter of Oddi Manometry

Chapter 17 Biliary Sphincterotomy

Video 17.1 Biliary Sphincterotomy: Biliary Cannulation

Video 17.2 Biliary Sphincterotomy: EST Double-Wire Biliary Cannulation

Video 17.3 Biliary Sphincterotomy and Prophylactic Pancreatic Duct

Stenting in Sphincter of Oddi Dysfunction

Video 17.4 Biliary Sphincterotomy

Video 17.5 Biliary Sphincterotomy

Chapter 18 Balloon Dilation of the Native and Postsphincterotomy

Papilla

Video 18.1 Balloon Dilation of the Major Papilla in Billroth II Gastrojejunostomy and Extraction of the Bile Duct Stone

Video 18.2 Sphincterotomy and Balloon Dilation of the Major Papilla

Video 18.3 Postsphincterotomy Large Balloon Dilation of the Major Papilla and Extraction of a Huge (4.5- × 2.0-cm) Stone

Video 18.4 Balloon Dilation of the Major Papilla and Extraction of Multiple Bile Duct Stones

Chapter 19 Stone Extraction

Video 19.1 Papillotomy and Basket Stone Extraction

Video 19.2 Papillotomy- and Papillotome-Assisted Stone Extraction Followed by Basket Stone Extraction

Video 19.3 Papillotomy, Balloon Sphincteroplasty, and Stone Extraction With Balloon

Video 19.4 Impacted Ampullary Stone

Chapter 20 Pancreatic Sphincterotomy

Video 20.1 Pancreatic Sphincterotomy

Chapter 21 Minor Papilla Cannulation and Sphincterotomy

Video 21.1 Minor Papilla Cannulation and Sphincterotomy

VIDEO CONTENTS

Chapter 23 Biliary Metal Stent Insertion

Video 23.1 Biliary Self-Expandable Stent Placement

Video 23.2 Biliary Self-Expandable Stent Placement

Chapter 24 Pancreatobiliary Stent Retrieval

Video 24.1 Endoscopic Technique for the Extraction of Pancreatic Stents: Snare and Forceps

Video 24.2 Endoscopic Technique for the Extraction of Pancreatic Stents: Direct Grasping With a Polypectomy Snare

Video 24.3 Endoscopic Technique for the Extraction of Pancreatic Stents: Lasso Technique

Video 24.4 Endoscopic Technique for the Extraction of Pancreatic Stents: Dormia Basket Technique

Video 24.5 Endoscopic Technique for the Extraction of Pancreatic Stents: Fragmentation and Direct Grasping

Chapter 25 Papillectomy and Ampullectomy

Video 25.1 Ampullary Adenoma

Chapter 26 Pancreatoscopy

Video 26.1 Video Pancreatoscopy of Intraductal Papillary Mucinous Neoplasm

Video 26.2 Intraductal Papillary Mucinous Neoplasm Biopsy Under Direct Vision

Chapter 27 Cholangioscopy

Video 27.1 Videocholangioscopy

Video 27.2 Image-Enhanced Videocholangioscopy Using NarrowBand Imaging

Video 27.3 1.9- to 3-Fr Electrohydraulic Lithotripsy or Laser Lithotripsy Using Holmium:YAG and FREDDY

Chapter 28 Endomicroscopy in the Pancreaticobiliary Tree

Video 28.1 Probe-Based Confocal Laser Endomicroscopy of the Bile Duct Showing Dark Clumps, Epithelium, and Fluorescein Leak, All Suggestive of Cancer

Chapter 31 ERCP in Surgically Altered Anatomy

Video 31.1 Cholangiography in Patient With Roux-en-Y Hepaticojejunostomy

Chapter 39 Malignant Biliary Obstruction: Distal

Video 39.1 Stenting in Pancreatic Cancer

Chapter 44 Biliary Surgery Adverse Events, Including Liver Transplantation

Video 44.1 Multistenting of a Postorthotopic Liver Transplantation Anastomotic Biliary Stricture

Chapter 46 Choledocholithiasis

Video 46.1 Second-Generation Peroral Cholangioscopy and Holmium:YAG Laser Lithotripsy for Rescue of Impacted Biliary Stone Extraction Basket

Video 46.2 Efficacy and Safety of a Single-Operator Digital Peroral Cholangioscopy–Guided Laser Lithotripsy of Complicated Biliary Stones

Video 46.3 Novel Use of Spyglass Optical Fiber in Triple-Lumen Catheter for Percutaneous Choledochoscopy and Holmium:YAG Laser Lithotripsy of Intrahepatic Bile Duct Stones

Chapter 47 Pancreaticobiliary Pain and Suspected Sphincter of Oddi Dysfunction

Video 47.1 Biliary Cannulation Using a Manometry Catheter Without Contrast Injection Freehand Without Biliary Cannulation

Video 47.2 Biliary Injection of Contrast and Pancreatic Cannulation Using a Manometry Catheter Without Contrast

Video 47.3 Biliary Manometry and Sphincterotomy

Video 47.4 Placement of a 3-Fr Pigtail Pancreatic Duct Stent

Video 47.5 Placement of a 5-Fr Straight Pancreatic Duct Stent

Video 47.6 Pancreatic and Biliary Sphincterotomy With Pancreatic Duct Stent Placement for Sphincter of Oddi Dysfunction

Video 47.7 Pancreatic and Biliary Sphincterotomy With Pancreatic Duct Stent Placement for Sphincter of Oddi Dysfunction

Video 47.8 Biliary Sphincterotomy for Sphincter of Oddi Dysfunction

Video 47.9 Use of Dilute Methylene Blue to Identify the Pancreatic Orifice After Biliary Sphincterotomy for Sphincter of Oddi Dysfunction

Chapter 48 Sclerosing Cholangitis

Video 48.1 Endoscopic Treatment of Dominant Primary Sclerosing Cholangitis Stricture

Chapter 49 Tropical Parasitic Infestations

Video 49.1 Endoscopic Biliary Sphincterotomy to Facilitate Extraction of Hydatid Cysts and Worms

Video 49.2 Use of Balloon Catheter Following Biliary Sphincterotomy

Chapter 50 Recurrent Pyogenic Cholangitis

Video 50.1 The Hallmark of Recurrent Pyogenic Cholangitis: The Presence of Stones and Strictures, Which Can Be Both Intrahepatic and Extrahepatic in Location

Video 50.2 Direct Peroral Cholangioscopy Using an Ultraslim Upper Endoscope Introduced Directly Into the Biliary Tree

Video 50.3 Direct Peroral Cholangioscopic Biopsy Using an Ultraslim Upper Endoscope

Video 50.4 Electrohydraulic Lithotripsy

Video 50.5 Ductal Changes Post–Stone Removal

Video 50.6 Alterations in Ductal Mucosa Post–Stone Removal

Chapter 51 Cystic Lesions of the Pancreas

Video 51.1 Endoscopic Ultrasound-Guided Ethanol Ablation of Pancreatic Cyst

Chapter 54 Pancreatic Interventions in Acute Pancreatitis: Ascites, Fistulae, Leaks, and Other Disruptions

Video 54.1 Transduodenal Pancreatic Duct Decompression

Video 54.2 Transpapillary Pseudocyst Drainage and Disconnected Pancreatic Duct Decompression in Pancreatic Pleural Effusion

Video 54.3 Internal Fistula/Duodenal Abscess Treated With Pancreatic Duct Stone Retrieval/Stent Placement/ Effusion

Chapter 55 Chronic Pancreatitis: Stones and Strictures

Video 55.1 Postextracorporeal Shock Wave Lithotripsy Pancreatic Stone Extraction

Chapter 56 Endoscopic Drainage of Pancreatic Pseudocysts, Abscesses, and Walled-Off (Organized) Necrosis

Video 56.1 Endoscopic Gastric Drainage of Pancreatic Pseudocyst

Video 56.2 Endoscopic Transduodenal Drainage of Pancreatic Necrosis

Video 56.3 Endoscopic Transduodenal Debridement of Pancreatic Necrosis

Video 56.4 Endoscopic Transduodenal Debridement of Pancreatic Necrosis

Video 56.5 Use of Partially Covered and Fully Covered SelfExpandable Stents to Establish Percutaneous Access for Endoscopic Necrosectomy

Video 56.6 Transgastric Drainage of Pancreatic Necrosis

SECTION I General Topics

1

Approaching 50 Years: The History of ERCP

Endoscopic retrograde cholangiopancreatography (ERCP) has been a remarkable technological advance that has evolved over its nearly 50 years in the field of gastrointestinal endoscopy and has redefined the medical and surgical approach to patients with pancreatic and biliary tract diseases. Since its inception in 1968, the medical community has witnessed significant achievements by the pioneers in endoscopy who incrementally advanced ERCP techniques from their infancy to maturity. The infancy focused on diagnoses, the adolescence on therapies of common biliary tract diseases such as bile duct stones and malignant strictures, the early adulthood on therapy for diseases of the pancreas and prevention of pancreatitis, and now the mature adulthood focuses on continued refinement of techniques to make ERCP safer and more effective. The pioneers in the ERCP field are numerous and have played significant roles in developing new techniques and novel instrumentation, spearheaded innovative techniques to reduce adverse events, and effectively trained future generations of endoscopists to safely perform ERCP. We are now approaching a 50-year milestone, and as we look back, we can recall a journey in ERCP that has been enjoyable, exciting, and replete with enthusiastic innovation, and in the end has benefitted many patients (Box 1.1). It would encompass an entire book to incorporate all of the important contributions made by the many ERCP endoscopists over the past 50 years. We apologize in advance to individuals who have advanced the field and are not mentioned in this brief summary of the history of ERCP.

ERCP IN ITS INFANCY: 1968 TO 1980

In the 1920s, bile duct imaging was performed by surgeons Evarts Graham and Warren Cole with the use of intravenously administered iodinated phenolphthalein that was selectively excreted into the bile and recorded radiographically. Oral cholecystography and percutaneous skinny “Chiba” needle cholangiography were additionally developed to improve the visualization of the bile duct.1,2 What defied the clinician was a nonoperative technique to image the pancreatic duct. In 1965 two innovative radiologists, Rabinov and Simon,3 fashioned a bendable catheter that was inserted through a per oral basket catheter. The medial duodenal wall was “blindly scratched” with the tip of the catheter and the first pancreatogram was successfully obtained nonoperatively. In eight attempts, an interpretable pancreatogram was obtained in two patients. The gastrointestinal endoscopist now entered the arena. In 1968 William McCune and his surgical colleagues at George Washington University were credited with the first report of endoscopic cannulation of the ampulla of Vater in living patients.4 McCune used an Eder fiberoptic

duodenoscope (Eder Instrument Company, Chicago, IL), which had both a forward and side lens and an endotracheal-type cuff placed on the scope just beyond the lens. The balloon was inflated and deflated to enable adequate focal length for mucosal visualization. McCune taped a small-diameter plastic tube that served as a tract to the endoscope that could house a bendable cannula. The cannula was advanced to the major duodenal papilla under endoscopic guidance. In his report of 50 patients, McCune’s duodenal intubation success rate was only 50%, with only 25% pancreatic duct opacification. As stated in his discussion: “Anyone who looks through one of these instruments has to have 2 personality characteristics. First, he has to be honest, and second, must have an undying, blind, day and night, uncompromising persistence.” ERCP was now born, and it slowly grew to an established technique as a result of the honesty and persistence of the pioneers of endoscopy.

In March 1969 in Japan, Oi (Fig. 1.1) and colleagues—in close collaboration with Machida (Machida Endoscope, Ltd., Tokyo, Japan) and Olympus corporations (Olympus Optical Co., Ltd., Tokyo, Japan)— developed a side-viewing fiberoptic duodenoscope with a channel and an elevator lever to enable manipulation of the cannula. Initially, Oi visualized the ampulla in about half of 105 cases.4 In a subsequent report, Oi cannulated the papilla in 41 of 53 patients (77%) without significant morbidity.5 By 1972, Jack Vennes and Steven Silvis of the University of Minnesota published the experience in their first 80 attempts at cannulation of the bile and pancreatic ducts, paving the way for acceptability in the American endoscopic wilderness6 ( Table 1.1).7,8 Over the next 5 years, pioneers such as Safrany, Cotton, Geenen, Siegel, Classen, and Demling and the Japanese groups embraced this new technique and reported on the successes (cannulation rates of >90%) (Fig. 1.2), the shortcomings (e.g., post-ERPC pancreatitis [PEP]), the nuances (variety of cannula types, cannulation angles), and the practical application of ERCP in our understanding of biliary and pancreatic disorders.9–15 But what could we as endoscopists do with this new-found knowledge?

Simultaneously in 1973, in separate regions on the globe, ERCP investigators conceived the concept of a therapeutic application of ERCP. The sphincter of the intact papilla served as a barrier to reflux of duodenal contents into the bile and pancreatic duct and was an impediment to removal of stones from the bile duct. Independently, Demling and Classen in Erlangen, Germany, and Kawai in Kyoto, Japan, developed similar techniques to split the sphincter. Demling and Classen developed a high-frequency diathermy snare, the Demling-Classen probe consisting of a Teflon catheter with a thin steel wire that could be protruded to create a “bowstring” that would sever the papillary muscle (Fig. 1.3).15–17

Lee McHenry and Glen Lehman

BOX 1.1 History of ERCP: Five Decades, Decade by Decade

1970s: Diagnosis and Therapy

• Locating the ampulla

• Biliary and pancreatic duct cannulation

• Interpretation of cholangiography and pancreatography, identifying pathology

• First reports of biliary sphincterotomy

• Developing the instruments: balloon extraction of bile duct stones and stent placement

1980s: Slowly Shifting from Surgery to Endoscopic Management of Pancreaticobiliary Disorders

• Refinement of accessories, improvements in radiographic imaging

• Reporting adverse events of sphincterotomy

• Biliary stent placement for obstructive jaundice and shift from palliative surgery

• Introduction of the teaching head: “seeing is believing”

• Acceptance of ERCP by the medical community

• Management of CBD stones shifts from surgery to endoscopy

• ERCP training gets its start for physicians and ERCP nurses

• Basic threshold numbers for competence

1990s: Training and Expanding Our Therapies

• More emphasis on advanced training

• Endoscopic photography and videography: sharing images with others

• Referring MDs, patients, and industry

• Comparison of one procedure to another

• Teaching and training

• “Theater presentations” of ERCP

• Therapies for pancreatic disorders: chronic pancreatitis, pseudocysts, and necrosis

• Era of laparoscopic cholecystectomy and bile duct injuries

• Safer sphincterotomy: monofilament wires and computer-regulated blended current

• Self-expandable metallic stents

• Complementary pancreaticobiliary techniques developed

• Endoscopic ultrasonography (EUS) and magnetic resonance cholangiopancreatography (MRCP)

2000s: Prevention, Pulverizing, and Peculiar Pancreas Diseases

• Pancreatic stents and post-ERCP pancreatitis prevention

• Improved techniques for extraction of “large” bile duct stones are implemented

• Papillary balloon dilation

• Single-operator system for intraductal lithotripsy

• Intraductal papillary mucinous neoplasm (IPMN) and autoimmune pancreatitis (AIP) recognized

• “Hands-on” courses

• EUS and ERCP therapeutic interface

2010s: Refinements of ERCP Techniques and New Treatments

• Pharmacologic agents (rectal NSAIDs) for post-ERCP prevention

• Revised recommendations for sphincter of Oddi dysfunction diagnosis and therapy

• ERCP scope infections are revisited and rigorous cleaning processes of ERCP scopes are revised

• Novel ERCP treatments for cholangiocarcinoma, including photodynamic therapy and radiofrequency ablation, are introduced

• Charge-coupled device (CCD) imaging improves intraductal cholangioscopy and pancreatoscopy

TABLE 1.1 ERCP in Its Infancy: Cannulation Rates Around 1972

541 86

145 94 Vennes 80 75

*Generally defined as entry into either duct.

From Cotton PB. Progress report: cannulation of the papilla of Vater by endoscopy and retrograde pancreatography (ERCP). Gut 1972;13:1014–1025.

Canine experiments ensued and demonstrated that a papillotomy could be performed safely without bleeding or perforation. An added benefit of the Demling-Classen probe was that contrast dye could be instilled while the catheter was in place. In Japan, Kawai developed a papillotomy device consisting of two separate 2-mm-long diathermy knives that protruded from the catheter tip and could be used to incise the papillary sphincter, similar to the present-day needle knife technique.15 This device was particularly useful in patients with impacted stones at the papilla. The Erlangen probe, because of a perceived reduction in the risk of perforation, was more accepted in the West, and sphincterotomy as a technique was born. The initial concern of postsphincterotomy scarring was postulated, but the incidence was found to be infrequent. The first

therapeutic application during ERCP, with incumbent well-chronicled risks, was gradually adopted by endoscopists around the world. Bile duct stones were accurately diagnosed at the time of cholangiography, biliary sphincterotomy was performed, and the stones were left in the bile duct to pass on their own. This clinical problem needed a solution, and as is true with the many endoscopic techniques, the fundamental elements for major endoscopic technological advances were borrowed heavily from other fields (i.e., urology: basket, stent, and balloon technology; radiology: catheter and guidewire technology; cardiology: catheters and metallic stents). To solve the clinical problem of removing stones from the bile duct, in 1975 Zimmon and colleagues18 in New York reported removal of bile duct stones with balloon-tipped catheters, a

technique that further expanded the endoscopist’s therapeutic armamentarium. Long, flexible balloon-tipped catheters, basket catheters, stone-grasping forceps, and endoscopic laser or ultrasound stone disintegrators were miniaturized to fit through the endoscope working channel, and removal of bile duct stones no longer required surgical laparotomy and open choledochotomy.

FIG 1.1 One year after Dr. William McCune successfully performed the first ERCP at George Washington University, in Japan Dr. Itaru Oi, with his chief, Dr. Takemoto, performed endoscopic cholangiopancreatogram (ECPG), as it was called, with a Machida scope in 1969.5 The method used was almost the same as Dr. McCune’s method of using a prolonged gastrofiberscope. In close collaboration with the Machida and Olympus corporations, Oi developed a side-viewing fiberoptic duodenoscope with a channel and an elevator lever to enable manipulation of the cannula. (Photo courtesy Dr. Peter Cotton, Medical University of South Carolina.)

The 1970s were an exciting time for ERCP, but many physicians (gastroenterologists and surgeons) were appropriately concerned about the dangers of the procedure, particularly PEP, bleeding, and biliary sepsis. In 1976, Bilbao and colleagues19 surveyed 402 U.S. owners of side-viewing duodenoscopes who had collectively performed 10,435 ERCPs. The procedure failed in 30%, adverse events occurred in 3%, and death occurred in 0.2%. Pancreatitis was associated with injection into the pancreatic duct and sepsis with injection into an obstructed bile duct. Inexperience led to a fourfold increase in failures (62%) and twice the rate of adverse events (7%). ERCP was the riskiest procedure for the endoscopist, yet was gradually embraced, and the physicians who had the willingness and ability to perform ERCP forged ahead. In looking back in ERCP history over the past 5 decades, the gastroenterology community was aware of the high incidence and potentially severe adverse events associated with ERCP; however, the absolute requirement of advanced training and expertise before subjecting patients to this potentially lethal procedure was understated, minimized, and inadequately addressed. These should serve as reminders and lessons for the future as new endoscopic procedures are introduced.

Malignant bile duct obstruction posed a problem to the ERCP physician in the 1970s. Endoscopic cannulation of the bile duct introduced bacteria-laden contrast dye into an obstructed biliary tree, and endoscopic sphincterotomy alone would not provide adequate biliary drainage except in the most distal bile duct or ampullary cancers. Percutaneous transhepatic methods for biliary drainage were commonly employed preoperatively in patients with deep jaundice or for palliation, and the first report of a percutaneous transhepatic cholangiography (PTC)-guided internal bile duct prosthesis was reported by Burcharth et al. in 1979.20 In 1980, the ERCP groups in England (Laurence and Cotton21) and Germany (Soehendra and Reynders-Frederix22) reported the early cases of internal decompression of malignant biliary obstruction by ERCP-directed biliary endoprosthesis placement (Fig. 1.4). The initial methods relied on “borrowed” technology and reported the uses of a 7-Fr nasobiliary drain fashioned from an angiographic catheter and a “pigtail” stent cut from a 7-Fr Teflon catheter. Over the next 30 years, with the aid of industry and ingenuity, biliary endoprosthesis design continued to advance from the back table of the craftsman/endoscopist to the precision engineering of multisized polyethylene stents and

FIG 1.2 In the early days: First ERCP by Dr. Ogoshi at the Niigata Cancer Center Hospital, Japan, in 1970. Radiographs showing complete pancreatography (left) and the distal bile duct (right). Note the long scope position to obtain pancreatography. (Photo courtesy Dr. Peter Cotton, Medical University of South Carolina.)

In the bottom middle is the limited field of view of the duodenal papilla on the left and the papilla after sphincterotomy on the right. (Photo courtesy Dr. Peter Cotton, Medical University of South Carolina.)

self-expandable metallic stents. Effective palliation of malignant biliary obstruction was wrestled from the surgeon and radiologist, and planted for good into the endoscopist’s hands.

THE SECOND DECADE: 1980 TO 1990

Over the next 10 years from 1980 to 1990, medicine witnessed an explosion in the number of ERCPs performed throughout the world. However, this explosion did not occur in a vacuum and was fueled by burgeoning technology in other medical disciplines such as radiology, anesthesia, pathology, and surgery. In 1979, the Nobel Prize in Medicine was awarded jointly to Godfrey N. Hounsfield (U.K.) and Allan McLeod Cormack (Tufts University, Medford/Somerville, MA) for independently inventing the computerized axial tomography (CAT) scanner. Assessment of the patient with pancreatobiliary disease was transformed from physical examination, ultrasound, and plain radiographs, and their inherent limitations to precise computed tomography (CT) characterization and localization of the problem at hand. Improved perioperative management and anesthesia care made the ERCP procedure more acceptable to patients. Pathologic interpretation of endoscopic biopsies and cytologic assessment of brushings continued to improve, with increased number of specimens and physician experience allowing tissue diagnosis to be made nonoperatively. The surgeon’s role evolved from exploration for diagnosis with its inherent morbidity and mortality to a more focused therapeutic operation that would lead to improved patient outcomes.

Industry played a major role in the close collaboration with endoscopists in designing improved versions of ERCP accessories, including cannulas, sphincterotomes, and endoscopic stents, which led to improved therapeutics and improved patient outcomes. Companies such as Wilson-Cook (now Cook Endoscopy, Winston-Salem, NC), Olympus (Center Valley, PA, and Tokyo, Japan), Bard (now ConMed, Utica, NY), and Microvasive (now Boston-Scientific, Marlborough, MA) and many

others forged tight, long-lasting relationships with the pioneers in ERCP, which accelerated innovation in the field (Fig. 1.5). Both ERCP endoscopists and patients benefited from increased cannulation rates, improved sphincterotomies, and reliable prostheses. The domain of bile duct stones and palliation of malignancies shifted from surgeons to endoscopists. One of the recurring themes in endoscopic advances is the importance of close collaboration of engineers and clinicians to attempt to solve clinical problems.

Fiberoptic endoscopy was the platform for the ERCP gastroenterologist in the 1970s and posed a challenge for performance of and training and reporting in ERCP. Documenting endoscopic findings was limited in quality, as the camera head attachment was bulky and, when affixed, precluded real-time visualization of the endoscopy image. To share the endoscopy experience, a teaching head apparatus would connect to the endoscope to allow a second observer (an ERCP trainee or procedural nurse) to visualize the endoscopic image. The major drawbacks were halving of the light transmitted through the fibers to the eyepiece, allowing only one observer on the teaching head, and limiting the nurse to the use of only one hand to perform important functions such as wire advancement while holding the teaching head with the other hand. The first videoendoscope had a small television camera in the tip of the endoscope (charge-coupled device [CCD]) and was connected to a computer capable of transforming electronic signals into a recognizable image. Sivak and Fleischer23 in the United States and Classen and Phillip24 in Germany reported on their first experiences in 1984. Videoendoscopy had transformed the ERCP experience for the performing physician, the trainees, and the ERCP nurses to a more dynamic, less solitary experience and launched ERCP training to a new level.

THE THIRD DECADE: 1990 TO 2000

In the decade of 1990 to 2000, several breakthrough technologies in radiology, endoscopy, and surgery were introduced that would impact

FIG 1.3 The endoscopic and fluoroscopic images from the first sphincterotomy performed by Drs. Nakajima and Kawai in Kyoto, Japan, in 1974. Clockwise from left: The fluoroscopic images on the left show the distal bile duct calculus (arrow) with upstream filling of the bile duct. The catheter was used for cannulation and sphincterotomy. On the right, the cholangiogram and pancreatogram revealing bile duct clear of filling defect.

FIG 1.4 ERCP-directed bile duct drainage using biliary stents was introduced by Soehendra and Reynders-Frederix from Hamburg, Germany, in 1979, adding to the armamentarium of therapeutic ERCP. The team used a 20-cm-long, 7-Fr radioopaque angiographic catheter with 12 side holes inserted over a guidewire with a single pigtail that allowed it to be fixed inside the bile duct. (Photo courtesy Dr. Peter Cotton, Medical University of South Carolina.)

FIG 1.5 Industry played a pivotal role in the field of ERCP. The Olympus duodenoscope model JF (pictured here with camera attached) was introduced in 1971. The JF duodenoscope was fiberoptic, had a 65-degree view angle, and was fitted with an elevator. The channel size was <2 mm diameter, limiting the size of catheters that could be used and making suctioning around the catheter problematic. (Photo courtesy Dr. David Barlow, Olympus Corporation.)

resonance cholangiopancreatography (MRCP) to image noninvasively the bile and pancreatic ducts.26,27 Endoscopic ultrasonography (EUS), originally described in 1980 by DiMagno et al.,28 was introduced with the radial scanning echoendoscope, which became a staple for clinical care in the late 1980s. Linear endosonography followed in 1994 and had the added advantage of diagnostic fine-needle aspiration. Laparoscopic cholecystectomy was first performed in 1987 by Mouret (unpublished) and reported in 1989 in Europe by Dubois et al.29 and Perissat et al.30 and in the United States by Reddick and Olsen.31 Laparoscopic cholecystectomy transformed the practice of ERCP, with more reliance on endoscopists to remove bile duct stones preoperatively or postoperatively.32

ERCP IN THE NEW MILLENNIUM

In the fourth and fifth decades, ERCP as an endoscopic procedure was widely available and practiced by many gastroenterologists in nearly every hospital with more than a 50-bed capacity. In the earlier decades of ERCP, the technique was adopted initially based on logic and began to grow based on cannulation success and eventually therapeutic success. There were few prospective, controlled, randomized, outcome-based studies in the early years, in part because of the excitement and enthusiasm of innovation and the lack of funding (and applications for funding) for endoscopic studies. The growth of ERCP decade by decade was in part attributable to the continued refinement of techniques and introduction of new innovations. In the new millennium, the “science of ERCP” has now become the focus. Prospective scientific studies have flourished since the year 2000, including studies evaluating the role of ERCP in gallstone pancreatitis,33 malignant biliary obstruction (preoperative endoscopic drainage followed by pancreaticoduodenectomy compared with primary pancreaticoduodenectomy alone),34 and sphincter of Oddi dysfunction (National Institutes Health–sponsored EPISOD trial) comparing sham therapy to manometrically directed sphincterotomy),35 and studies using pancreatic stents and pharmacologic agents to prevent PEP.36 Comparative trials evaluating novel therapies for cholangiocarcinoma, including photodynamic therapy (PDT) and radiofrequency ablation (RFA), emerged.

the field of pancreaticobiliary disease and the ERCP endoscopist. These technologies blossomed and ultimately transformed the indications for ERCP from a diagnostic/therapeutic procedure to a predominately therapeutic one.25 This transformation was driven in part by the introduction of magnetic resonance imaging (MRI)/magnetic

With the benefit of hindsight, in the 5-decade history of ERCP we could pose the following: What were the shortcomings of the incorporation of this technology into standard clinical practice? The risks of ERCP were underrecognized and underreported, particularly with respect to pancreatitis and perforation.37 An attempt to stratify patients at the greatest risk for PEP was not addressed until the fourth decade by Freeman and colleagues in 2001.38 Informed consent for ERCP was cursory, and in many instances, full disclosure of the potential risks and severity of adverse events was not provided to patients. Self-training was the norm in the first decade of ERCP, but advanced training became more readily available in the 1980s and 1990s. The endoscopy societies were lax in guiding ERCP training programs and community hospitals in the number of ERCPs necessary to attain a base level of competence. The Gastroenterology Core Curriculum of the Gastroenterology Leadership Council (joint effort of the American Association for the Study of Liver Diseases [AASLD], American College of Gastroenterology [ACG], American Gastroenterological Association [AGA], and American Society for Gastrointestinal Endoscopy [ASGE]) in 1996 did not recommend a specific number of ERCPs necessary to assess competence. An early ASGE guideline recommended 100 ERCP procedures (75 diagnostic and 25 therapeutic) as the minimum number of ERCPs before one could assess competency. The threshold still remains unclear, with the suggestion that at least 180 procedures are necessary.39 Yearly ERCP volume by the endoscopist practicing ERCP has not been established to guide credentialing agencies.

A “shift” of high-risk, complicated ERCP procedures to referral centers is reflected in the growing number of ERCPs performed at our institution over the past 15 years (Fig. 1.6). Hands-on training opportunities for practicing gastroenterologists to improve ERCP skills are scarce, and real-life simulators for ERCP are still not available.

KEY POINTS

• In the early years of ERCP in the 1970s, pioneers such as McCune, Oi, Classen, Kawai, Cotton, Vennes, Silvis, Geenen and others established a new technology.

• Close collaboration was vital between the endoscopist and industry to design new instrumentation, leading to higher cannulation rates, improved sphincterotomy, more effective drainage techniques, and improved outcomes.

• The early adopters of ERCP were self-taught, and subsequent trainees were schooled using the apprentice model. Training accelerated with

THE FUTURE OF ERCP

As we look back at the history of ERCP, we can take time to speculate about ERCP in the future. Capsule cameras and remote-guided cameras may complement or replace handheld gastroscopy, enteroscopy, and colonoscopy, but we foresee that endoscopic cannulation of the pancreaticobiliary system will remain the standard. Improvements with CCDs, even smaller-diameter choledochoscopes, and pancreatoscopes are eagerly awaited and should soon become a practical reality. However, optimal view, steerability, and durability remain as challenges. Hands-free manipulation of endoscopes, similar to robotic-assisted surgery, is anticipated with the advantages of reduced endoscopist fatigue, improved ability to train endoscopists, and more refined movement of accessories. Pancreaticobiliary tumor diagnosis and tissue sampling will undoubtedly improve with advances in intraductal endoscopy. Endoscopic pancreatic cancer screening of high-risk groups may become a reality. Pancreatitis management may benefit from a more defined endoscopic role. Dissolution of intraductal pancreatic stones may be possible with the aid of endoscopically placed catheters. Studies of pancreatic juice may provide predictors of recurrent pancreatitis, pancreatic cancer risk, and response to chemotherapy. Continued effort is needed to make ERCP safer and more effective. Advanced training programs must continue to ensure that ERCP endoscopists are adequately trained and skilled in the performance of this procedure.

The complete reference list for this chapter can be found online at www.expertconsult.com

introduction of videoendoscopy. Minimum qualifications for ERCP competency were poorly defined.

• In the new millennium, ERCP endoscopists have emphasized scientific rigor with several prospective, outcome-based studies. Newer techniques such as prophylactic pancreatic stent placement were adopted to make ERCP safer in high-risk patients.

FIG 1.6 ERCP case volume over 25 years at the Indiana University Division of Gastroenterology.

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The ERCP room can range from very basic to state-of-the-art. Whereas smaller institutions with low ERCP volumes often perform ERCP in the radiology department or operating room, most centers with a larger ERCP volumes perform ERCP in dedicated rooms within the endoscopy unit. The basic ERCP room requires a quality fluoroscopy unit with still-image capability in addition to standard endoscopic equipment. Major innovations in the field of interventional endoscopy have led to the development of multipurpose interventional rooms with the ability to combine endoscopic ultrasonography (EUS), cholangioscopy, pancreatoscopy, confocal endomicroscopy, and other interventions in combination with ERCP. A well-designed ERCP room is needed to accommodate this expansion in the procedural intensity of ERCP. In addition, changes in the patient population have led to the necessity to be able to perform ERCP on morbidly obese patients and those with altered anatomy using deep enteroscopy instruments. Many centers have moved to have anesthesia support for all ERCPs. The cumulative effect of these changes in the practice of ERCP has led to significant changes in the design of the typical ERCP room with the incorporation of new technology to benefit the patient, physician, and staff.

EVOLUTION OF THE ERCP ROOM

The basic intent of ERCP has not changed. Endoscopic visualization of the ampulla and cannulation of the desired ductal system with high-quality radiographic imaging guiding the appropriate therapy is still the goal. In the great majority of cases the basic equipment is all that is needed to remove a stone or place a stent across uncomplicated strictures. What has changed is the potential complexity of ERCP, especially at tertiary referral centers. The need for high-quality radiographic imaging of focal pathology in larger patients has led to modified digital fluoroscopy equipment with improved resolution, reduced radiation exposure, and the ability to function continuously for long procedures without overheating. In addition, wider tables (>30 inches) capable of accommodating larger, heavier patients (≥450 lbs.) and space for anesthesia to assist in these procedures have become essential. Additional room space is also needed to accommodate larger beds and stretchers to allow for bariatric patients (Fig. 2.1). The use of a mobile or fixed C-arm system is often employed to improve visualization of the biliary tree by allowing the plane of examination to be altered to profile the bifurcation and selected ductal systems. Additional space for supplemental equipment for cholangioscopy, EUS, laser lithotripsy, electrohydraulic lithotripsy, deep enteroscopy, and other adjuvant techniques has increased the size of the typical advanced ERCP room. Space for anesthesia equipment has further increased the need for additional space at the patient’s head. All this, in combination with the need to accommodate morbidly obese patients and store a large variety of devices in close proximity to the patient, has increased the size of well-designed, advanced interventional endoscopy rooms to greater than 500 square feet.

The ERCP Room

STAFFING FOR THE ERCP PROCEDURE

Staffing for ERCP procedures varies across the world. Typically, a physician and a minimum of two additional assistants are necessary. The first assistant (nurse or technician) stands immediately adjacent to the physician and operates devices such as guidewires and accessories. A sedation nurse or member of the anesthesia staff is positioned at the patient’s head and administers sedation or anesthesia while monitoring the patient throughout the procedure. Often, a second assistant (nurse or technician) assists in preparing devices for use and documents specifics of the procedure. In some settings a radiology technician is also needed to operate the radiographic equipment. In many centers, a trainee is often present. This creates a close working environment for the procedure with at least three individuals clustered around the patient’s head. A well-designed workspace makes this proximity tolerable and efficient.

ROOM LAYOUT

The key to successful room design is early collaboration with all the disciplines that will be involved in performance and delivery of ERCP so that the room is functional and beneficial to all parties. Collaborative input from ERCP physicians, the endoscopy nursing team and technicians, anesthesia team, patient advocates, radiologists and technicians, radiation safety technicians, the ergonomics consultant, and the construction or design team can result in major design evolution to allow the final design to be optimized for the work group. The layout of a typical tertiary-level ERCP room is depicted in Fig. 2.2. The ERCP room can be divided into multiple work areas. The epicenter of the ERCP room is the fluoroscopy table. The physician stands adjacent to the patient’s head while performing ERCP. In this room design the physician also has direct access to the radiographic equipment controls that allow movement of the fixed C-arm or table to obtain the optimum radiographic imaging. The first assistant’s workspace is immediately to the right of the physician. Space for a trainee is preferably located immediately to the physician’s left side. Adjacent to the first assistant’s work space is a preparation area for a second assistant with a countertop or movable table to prepare devices. This space should be immediately adjacent to the in-room storage of the most often used devices. Directly above the patient’s head is space for the sedation nurse or anesthesia team member. This space also includes room for all necessary medications, monitoring equipment, and resuscitative equipment. When using anesthesia, often there are two carts: the anesthesia machine at the patient’s head, and a secondary cart for medication and equipment storage, which must be within easy reach of the anesthesia provider. An optimal room design will allow ample space for these pieces of equipment, and easy access to all spaces during the procedure. Ideally, adequate additional space for radiograph review and report generation should be available. This space may be behind a protective lead glass screen or in another space altogether. In some configurations, a separate control room space for

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