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 Adler
Self-Expanding

Self-Expanding Stents
Stents
in Gastrointestinal Endoscopy
There is a tremendous interest in information on stents in the world of gastrointestinal
endoscopy. Many physicians did not train in an era where these stents were
available, but they are now being called upon to place them. Self-Expanding Stents
in Gastrointestinal Endoscopy looks to provide physicians with the necessary and
unique all-in-one resource on stents.

Self-Expanding Stents in Gastrointestinal Endoscopy by Dr. Douglas G. Adler covers

the use of self-expanding stents. This book will cover the use of all available devices
in all clinical contexts, with step-by-step instructions from experts in the field on
how to use them and, just as importantly, what not to do when using these devices.

Self-Expanding
Self-Expanding Stents in Gastrointestinal Endoscopy is illustrated with more than

in Gastrointestinal Endoscopy
150 color photographs, as well as many tables and diagrams.

Benefits and Features:

Stents
• Soup-to-nuts format covers the use of all devices available on the market in
all clinical situations
• All chapters authored by recognized experts in the world of stents who have
independently published extensive research in gastrointestinal endoscopy
• Over 150 color photographs to guide readers from start to finish through all
steps of learning about the procedures in Gastrointestinal Endoscopy
Self-Expanding Stents in Gastrointestinal Endoscopy brings attention to the use
of self-expanding stents in benign and malignant diseases, the avoidance and

SLACK
management of complications,
® and the future of these devices.

Self-Expanding Stents in Gastrointestinal Endoscopy is the perfect go-to book for

I N C all
O R practicing
P O R A Tgastroenterologists,
E D fellows, and general and colorectal surgeons.
Editor: Douglas G. Adler
SLACK
SLACK
I N C O R P O R A T E D

ack slackbooks.com
I N C O R P O R A T E D

MEDICAL/Gastroenterology
SLACK Incorporated
®

SLACK
®

I N C O R P O R A T E D
DOUGLAS G. ADLER, MD, FACG, AGAF, FASGE
Associate Professor of Medicine
Director of Therapeutic Endoscopy
Gastroenterology and Hepatology
University of Utah School of Medicine
Huntsman Cancer Institute
Salt Lake City, Utah
www.slackbooks.com
ISBN: 978-1-61711-028-3
Copyright © 2012 by SLACK Incorporated

All rights reserved. No part of this book may be reproduced, stored in a retrieval system or transmitted in any
form or by any means, electronic, mechanical, photocopying, recording or otherwise, without written permis-
sion from the publisher, except for brief quotations embodied in critical articles and reviews.

The procedures and practices described in this publication should be implemented in a manner consistent with
the professional standards set for the circumstances that apply in each specific situation. Every effort has been
made to confirm the accuracy of the information presented and to correctly relate generally accepted practices.
The authors, editors, and publisher cannot accept responsibility for errors or exclusions or for the outcome of
the material presented herein. There is no expressed or implied warranty of this book or information imparted
by it. Care has been taken to ensure that drug selection and dosages are in accordance with currently accepted/
recommended practice. Off-label uses of drugs may be discussed. Due to continuing research, changes in gov-
ernment policy and regulations, and various effects of drug reactions and interactions, it is recommended that
the reader carefully review all materials and literature provided for each drug, especially those that are new or
not frequently used. Some drugs or devices in this publication have clearance for use in a restricted research
setting by the Food and Drug and Administration or FDA. Each professional should determine the FDA status
of any drug or device prior to use in their practice.

Any review or mention of specific companies or products is not intended as an endorsement by the author or
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Library of Congress Cataloging-in-Publication Data

Self-expanding stents in gastrointestinal endoscopy / [edited by] Douglas G. Adler.

p. ; cm.
Includes bibliographical references and index.
ISBN 978-1-61711-028-3 (alk. paper)
I. Adler, Douglas G., 1969-
[DNLM: 1. Endoscopy, Gastrointestinal--methods. 2. Stents. WI 141]

616.3’307545--dc23
2012000349

For permission to reprint material in another publication, contact SLACK Incorporated. Authorization to pho-
tocopy items for internal, personal, or academic use is granted by SLACK Incorporated provided that the ap-
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 DEDICATION
For my father, who never gave up.
 CONTENTS
Dedication................................................................................................................................. v
Acknowledgments.....................................................................................................................ix
About the Editor ......................................................................................................................xi
Contributing Authors ........................................................................................................... xiii
Preface ...................................................................................................................................xvii

Chapter 1 Esophageal Stents in Benign Disease ..........................................................1

Sanjay R. Hegde, MD and Eric Goldberg, MD

Chapter 2 Esophageal Stents in Preoperative Esophageal Cancer Patients ............. 21

Kathryn R. Byrne, MD; John C. Fang, MD; and
Douglas G. Adler, MD, FACG, AGAF, FASGE

Chapter 3 Esophageal Stents in Patients With Malignant Dysphagia

Due to Unresectable Disease ..................................................................... 35
Kulwinder S. Dua, MD, FACP, FRCP, FASGE

Chapter 4 Complications of Esophageal Stents and Their Management ................ 59

Gulshan Parasher, MD and Jess D. Schwartz, MD, FACS, FCCP

Chapter 5 Metal Biliary Stents in Benign Pancreaticobiliary Disease .....................77

Michelle A. Anderson, MD, MSc and Richard S. Kwon, MD, MSc

Chapter 6 Metal Biliary Stents in Patients With Potentially Resectable

Pancreaticobiliary Malignancy ................................................................. 93
Tyler M. Berzin, MD, MS; Ram Chuttani, MD; and
Douglas K. Pleskow, MD, AGAF, FASGE

Chapter 7 Metal Biliary Stents in Patients With Unresectable

Pancreaticobiliary Malignancy ............................................................... 109
Waqar Qureshi, MD, FRCP, FASGE

Chapter 8 Metal Biliary Stent Complications and Their Management ................. 121
Jessica I. Chan, BS, MS and Douglas G. Adler, MD, FACG, AGAF, FASGE

Chapter 9 Gastroduodenal Stents ............................................................................. 139

Christopher J. DiMaio, MD

Chapter 10 Gastroduodenal Stents Versus Surgery for Malignant Gastric

Outlet Obstruction................................................................................... 167
Ali A. Siddiqui, MD
viii Contents

Chapter 11 Colonic Stents as a Bridge to Surgery in Patients With

Colonic Obstruction ................................................................................ 181
John Y. Nasr, MD and Andres Gelrud, MD, MMSc

Chapter 12 Colonic Stents as Palliative Therapy in Patients With Malignant

Large Bowel Obstruction ......................................................................... 193
Sergey V. Kantsevoy, MD, PhD

Chapter 13 Complications of Colonic Stenting and Their Management ............... 207

Sonia Gosain, MD; Kevin Halsey, MD; and Peter Darwin, MD

Chapter 14 The Future of Self-Expanding Stents in

Gastrointestinal Endoscopy..................................................................... 219
Jeffrey L. Tokar, MD

Financial Disclosures ............................................................................................................235

 ACKNOWLEDGMENTS
I am indebted to Carrie Kotlar of SLACK Incorporated for her help with and support
for this project. Her steadfast backing of this project allowed for the conversion of an idea
into a reality. I am also deeply indebted to my loving wife and children for their unwaver-
ing support of this endeavor and all of the resources it required.
 ABOUT THE EDITOR
Douglas G. Adler, MD, FACG, AGAF, FASGE received his medical degree from Cornell
University Medical College. He completed his residency in internal medicine at Beth Israel
Deaconess Medical Center/Harvard Medical School. Dr. Adler completed both a general
gastrointestinal fellowship and a therapeutic endoscopy/endoscopic retrograde cholan-
giopancreatography fellowship at Mayo Clinic in Rochester, Minnesota. He then returned
to the Beth Israel Deaconess Medical Center for a fellowship in endoscopic ultrasound.
Dr. Adler is currently an Associate Professor of Medicine and Director of Therapeutic
Endoscopy at the University of Utah School of Medicine in Salt Lake City. Working
mostly out of the School of Medicine’s Huntsman Cancer Institute, Dr. Adler’s clinical,
educational, and research efforts focus on the diagnosis and management of patients with
gastrointestinal cancers, with an emphasis on therapeutic endoscopy. He is the author
of more than 150 scientific publications and book chapters and editor of the previously
published book Curbside Consultation in GI Cancer for the Gastroenterologist: 49 Clinical
Questions.
 CONTRIBUTING AUTHORS
Michelle A. Anderson, MD, MSc (Chapter 5)
Assistant Professor of Medicine
University of Michigan School of Medicine
Division of Gastroenterology
Ann Arbor, Michigan

Tyler M. Berzin, MD, MS (Chapter 6)

Staff Physician, Center for Advanced Endoscopy
Division of Gastroenterology
Beth Israel Deaconess Medical Center
Harvard Medical School
Boston, Massachusetts

Kathryn R. Byrne, MD (Chapter 2)

Assistant Professor
University of Utah School of Medicine
Division of Gastroenterology and Hepatology
Salt Lake City, Utah

Jessica I. Chan, BS, MS (Chapter 8)

University of Utah School of Medicine
Salt Lake City, Utah

Ram Chuttani, MD (Chapter 6)

Director of Endoscopy
Chief, Interventional Gastroenterology
Beth Israel Deaconess Medical Center
Harvard Medical School
Boston, Massachusetts

Peter Darwin, MD (Chapter 13)

Associate Professor
University of Maryland School of Medicine
Department of Gastroenterology and Hepatology
Baltimore, Maryland

Christopher J. DiMaio, MD (Chapter 9)

Director of Therapeutic Endoscopy
Assistant Professor of Medicine
Division of Gastroenterology
Mount Sinai School of Medicine
New York, New York
xiv Contributing Authors

Kulwinder S. Dua, MD, FACP, FRCP, FASGE (Chapter 3)

Professor, Department of Medicine
Medical College of Wisconsin
Division of Gastroenterology and Hepatology
Milwaukee, Wisconsin

John C. Fang, MD (Chapter 2)

Associate Professor
University of Utah Health Sciences Center
Department of Gastroenterology and Hepatology
Salt Lake City, Utah

Andres Gelrud, MD, MMSc (Chapter 11)

Associate Professor of Medicine
University of Pittsburgh Medical Center
Division of Gastroenterology, Hepatology, and Nutrition
Pittsburgh, Pennsylvania

Eric Goldberg, MD (Chapter 1)

Assistant Professor of Medicine
Director of Endoscopic Training and Research
University of Maryland School of Medicine
Baltimore, Maryland

Sonia Gosain, MD (Chapter 13)

GI Fellow
University of Maryland School of Medicine
Division of Gastroenterology and Hepatology
Baltimore, Maryland

Kevin Halsey, MD (Chapter 13)

Assistant Professor
University of Missouri Healthcare
Department of Gastroenterology and Hepatology
Columbia, Missouri

Sanjay R. Hegde, MD (Chapter 1)

Assistant Professor of Medicine
Division of Gastroenterology
Tufts Medical Center
Boston, Massachusetts
Contributing Authors xv

Sergey V. Kantsevoy, MD, PhD (Chapter 12)

Director of Therapeutic Endoscopy
The Melissa L. Posner Institute for Digestive Health and Liver Disease
Mercy Medical Center
Baltimore, Maryland

Richard S. Kwon, MD, MSc (Chapter 5)

Assistant Professor
Division of Gastroenterology
University of Michigan Medical School
Ann Arbor, Michigan

John Y. Nasr, MD (Chapter 11)

Gastroenterology Fellow
University of Pittsburgh Medical Center
Division of Gastroenterology, Hepatology, and Nutrition
Pittsburgh, Pennsylvania

Gulshan Parasher, MD (Chapter 4)

Associate Professor of Medicine
Director of Endoscopic and Clinical Services
Division of Gastroenterology and Hepatology
University of New Mexico School of Medicine
Albuquerque, New Mexico

Douglas K. Pleskow, MD, AGAF, FASGE (Chapter 6)

Associate Clinical Professor of Medicine
Harvard Medical School
Co-Director of Endoscopy
Beth Israel Deaconess Medical Center
Boston, Massachusetts

Waqar Qureshi, MD, FRCP, FASGE (Chapter 7)

Professor of Medicine
Chief of Endoscopy
Baylor College of Medicine
Houston, Texas

Jess D. Schwartz, MD, FACS, FCCP (Chapter 4)

Assistant Professor of Surgery
University of New Mexico Health Science Center
Department of Surgery
Division of Thoracic and Cardiovascular Surgery
Albuquerque, New Mexico
xvi Contributing Authors

Ali A. Siddiqui, MD (Chapter 10)

Associate Professor of Medicine
Division of Gastroenterology and Hepatology
Jefferson Medical College
Philadelphia, Pennsylvania

Jeffrey L. Tokar, MD (Chapter 14)

Assistant Professor
Fox Chase Cancer Center
Department of Medicine
Director, GI Endoscopy
Philadelphia, Pennsylvania
 PREFACE
In 1999, when I was a brand new gastroenterology fellow at the Mayo Clinic in
Rochester, Minnesota, I performed my first endoscopic stenting procedure: the placement
of an esophageal stent in a patient with malignant dysphagia from metastatic esophageal
cancer. I was amazed at the speed and ease of the procedure from a technical standpoint,
and I was nothing short of astonished at how soon the patient’s dysphagia symptoms
improved. This procedure, for me, was truly “ground zero” and my formal introduction
to the world of interventional and therapeutic endoscopy, and I knew that it would shape
my career from that point on.
A short time later, I assisted Dr. Todd H. Baron in the placement of a colonic stent in a
patient with a life-threatening malignant large bowel obstruction. The patient was criti-
cally ill and clinically unstable, and the surgeons were understandably less than enthusi-
astic about operating. In contrast to the aforementioned esophageal stent placement pro-
cedure, this case was neither speedy nor easy. Our endoscopic visualization was terrible,
the fluoroscopy unit we had at our disposal was ancient, and the malignant stricture in
question was sharply angulated, all of which complicated our efforts at every step of the
case. We were able to complete the procedure, but we emerged from the endoscopy room
drenched in sweat and concerned that we might have caused a perforation. Fortunately
for all concerned, there were no complications and the patient was able to decompress her
large bowel and proceed to an elective surgery at a later date. Despite the risks involved, it
was very exciting stuff for me. I remember commenting afterward that I felt like Dr. Baron
and I were somewhat analogous to Neil Armstrong and Buzz Aldrin landing on the moon
in the Sea of Tranquility in 1969; both endeavors were risky, utilized new and relatively
untested technology, and in one way or another lives were on the line.
Fast forwarding to the current day, self-expanding metal stents (SEMS) have come a
long way. Stent placement of any kind was once regarded as a high-end procedure, per-
formed rarely and only at a tertiary referral center. Now, self-expanding stents of all kinds
(esophageal, biliary, gastroduodenal, and colonic) are placed on a daily basis in a variety
of settings by endoscopists in an almost routine fashion. The literature on these stents
has expanded exponentially, as have the number and types of SEMS currently available
around the world. There is an enormous interest in these devices from the point of view
of patients, physicians (gastroenterologists, oncologists, and surgeons, among others), and
industry, and innumerable stent-related research studies are being carried out at this time
around the globe.
I utilize SEMS of all kinds in my daily practice as a therapeutic endoscopist at a large
tertiary referral cancer center, and I know for a fact that without these devices we would
be profoundly handicapped with regard to the treatment of dozens of conditions. Over a
decade after my first stent placement, I still find stent technology to be both fascinating
and miraculous.
In creating this book, I wanted to craft a definitive resource for physicians regarding
the use of any type of SEMS in any clinical situation that one might face. In the pages
that follow, esophageal, biliary, gastroduodenal, and colonic stents are reviewed in great
xviii Preface

detail. Each chapter includes a great number of endoscopic and radiologic images to fully
convey key concepts to the reader. Complications and limitations of stent technology are
covered as well in an attempt to minimize poor outcomes. Lastly, a chapter on the future
of SEMS is included to highlight the developmental nature of stent technology and to also
demonstrate that the best is yet to come.
I hope that you find this book to be a helpful and valuable addition to your library and
an aid to your daily clinical practice.

Douglas G. Adler
Salt Lake City, Utah
 Esophageal Stents in

1 Benign Disease

Sanjay R. Hegde, MD and Eric Goldberg, MD

Esophageal stents have an established role in the palliation of dysphagia in patients

with malignant esophageal strictures.1,2 However, the role of esophageal stents in benign
esophageal disorders is still evolving. This chapter will review applications of esophageal
stents in a variety of benign esophageal disorders, including refractory benign esophageal
strictures and esophageal perforations, leaks, and fistulae.

REFRACTORY BENIGN ESOPHAGEAL STRICTURES

Benign esophageal strictures are common in clinical practice. Dysphagia is typically
associated with narrowing of the luminal diameter of the esophagus to 13 mm or greater.3
Additionally, dysphagia can be objectively scored using a widely used dysphagia score that
can be useful in gauging treatment response (Table 1-1).
Historically, the most common etiology for benign esophageal strictures has been
so-called “acid-peptic” strictures related to gastroesophageal reflux disease (GERD).
However, the incidence and frequency of anastomotic and radiation related strictures has
increased in recent years.4
The majority of benign esophageal strictures respond to esophageal dilation therapy
within 1 to 3 dilation sessions. Approximately 25% to 35% of benign esophageal strictures
require additional dilation sessions.5 Esophageal dilation is safe and has a relatively low
complication rate including a 0.1% to 0.4% perforation rate and 0.1% risk of significant
bleeding.6,7 Dilation therapy can be performed using either a bougie or a hydrostatic bal-
loon dilator. Neither modality has demonstrated superiority in the immediate relief of
dysphagia or the need for repeat dilation at 1 year.8
Complex strictures are less likely to respond successfully to dilation therapy and can be
technically more difficult to dilate. The features of complex strictures include (1) length
greater than 2 cm, (2) angulation, (3) irregular contour, and (4) a severely narrowed luminal
diameter (Table 1-2). Additionally, anastomotic strictures along with strictures related to
radiation therapy or caustic injury have lower response rates to dilation therapy.4 The use of
fluoroscopy or narrow diameter endoscopes may aid in the management of such strictures.
There is no consensus on the definition for refractory esophageal strictures. However,
a recent definition proposed by Kochman et al has proven useful and has been applied in

Adler DG, ed. Self-Expanding Stents

-1- in Gastrointestinal Endoscopy (pp 1-20).
© 2012 SLACK Incorporated.
2 Chapter 1

Table 1-1. Dysphagia Score

Score Symptoms
0 No dysphagia
1 Intermittent solid food dysphagia
2 Unable to swallow solids
3 Unable to swallow pureed food
4 Unable to swallow liquids
Reprinted with permission from Mellow MH, Pinkas H. Endoscopic laser therapy for malignancies affecting the esophagus
and gastroesophageal junction. Analysis of technical and functional efficacy. Arch Intern Med. 1985;145(8):1443-
1446. Copyright © 1985 American Medical Association. All rights reserved.

Table 1-2. Features of Complex Esophageal Strictures

Length >2 cm
Angulation
Irregular contour
Severely narrowed luminal diameter

several studies investigating the treatment and management of refractory benign esopha-
geal strictures. A refractory stricture may be defined as an anatomic restriction due to cica-
tricial luminal compromise or fibrosis that results in the clinical symptom of dysphagia in
the absence of inflammation. Such strictures cannot be dilated to a diameter of 14 mm or
greater over 5 dilation sessions at 2-week intervals. A stricture may be defined as recurrent
when one cannot maintain a satisfactory luminal diameter for 4 weeks once the target
diameter of 14 mm has been achieved.9
When a stricture meets criteria for a refractory stricture, alternatives to dilation
therapy should be considered. Intralesional steroid injection with 4-quadrant injections
of 0.5 mL of 40 mg/mL triamcinolone within the narrowest point of the stricture in com-
bination with dilation therapy and twice-daily proton pump inhibitor (PPI) therapy have
been shown to increase the time interval between dilation sessions.10 Another approach to
refractory strictures involves the use of electrocautery with a needle-knife to disrupt the
stricture. This strategy has been used with variable success.11,12 Additionally, self-dilation
therapy can be considered in highly motivated patients.13 When these measures fail or are
not viable options, one may consider placement of an esophageal stent for the treatment
of a benign refractory esophageal stricture.

STENTS AND BENIGN ESOPHAGEAL

STRICTURES: AN OVERVIEW
Esophageal stents have been evaluated for use in the treatment of benign esophageal
strictures. Currently, only one self-expanding plastic stent (SEPS), the Polyflex stent
Esophageal Stents in Benign Disease 3

(Boston Scientific, Natick, MA), has been approved by the Food and Drug Administration
(FDA) for use in benign esophageal disease. Partially covered self-expanding metal stents
(PCSEMS) have been studied with unfavorable results, mostly related to the difficulty of
their removal. Recently developed, fully covered self-expanding metal stents (FCSEMS)
such as the Alimaxx-E and ES stents (Merit Endotek, South Jordan, UT) and the Boston
Scientific Fully Covered Wallflex stent are also available but are currently not FDA
approved for the management of benign esophageal strictures, and their use in patients
with benign disease must be considered off-label.
The ideal stent for treatment of benign esophageal disorders should have the following
characteristics: easy deployment, easy removability, low rate of migration, high rate of symp-
tomatic relief/resolution of underlying problem, and low complication rate.2
Currently, no available stents are ideal, but early results with SEPS and FCSEMS hold
promise for better results with improved stent design in patients with refractory benign
esophageal strictures, perforations, leaks, and fistulae.

Self-Expanding Plastic Stent /Polyflex Stent

The Polyflex SEPS is currently the only available stent that is FDA approved for the
treatment of benign esophageal disease. Polyflex stents are composed of a polyester net-
ting embedded with a silicone inner lining. These stents are impregnated with radio-
opaque markers at the proximal end, midpoint, and distal end of the stent to aid position-
ing during deployment. The proximal end of this stent is flared to prevent distal migration
while the mid and distal portions of the stent are of the same diameter as the main portion
of the stent shaft. The inner diameter of the shaft and distal end of the stent are available
in sizes of 16, 18, and 21 mm, with 20, 23, and 28 mm proximal flare sizes, respectively.
The stent delivery system is assembled by the physician immediately prior to deployment.
The assembly process can be challenging even for experienced endoscopists and can be
considered a drawback for the use of this stent. The introducer systems range in size from
12 to 14 mm, depending on the diameter of the stent to be utilized. Deployment is per-
formed under fluoroscopic guidance over a guidewire, with or without endoscopic guid-
ance from an endoscope advanced alongside the stent delivery catheter. When selecting
the length of a stent, it should cover the entire stricture. The endoscopists should leave
approximately 1 to 2 cm of stent above and below the stricture, anatomy permitting.
Once deployed, this stent can be repositioned or removed from either the esophagus or
the stomach (if the stent has migrated) using a rat-tooth forceps at the proximal edge of
the stent with steady, constant traction that allows the stent to dislodge from the esopha-
geal wall. A modification of this technique uses a 2-channel therapeutic upper endoscope
with 2 rat-tooth forceps simultaneously grasping the proximal aspect of the stent. The
forceps are crossed over one another by applying torque on the scope, and then the stent
is removed with gentle traction. Additionally, the distal aspect of the stent can be grasped
with a rat-tooth forceps, invaginating the stent into itself when traction is applied, thus
facilitating removal. Finally, polypectomy snares can also be used to lasso the stent, there-
by facilitating proximal repositioning or removal of these stents14 (Figures 1-1 and 1-2).
Early studies investigating the use of SEPS for benign esophageal strictures demon-
strated high rates of technical success for deployment (greater than 95%) and favor-
able clinical outcomes. In a study of 15 patients with benign esophageal strictures by
Repici et al, technical success was reported in 100% of patients and clinical success in
4 Chapter 1

Figure 1-1. Endoscopic image of a Polyflex stent

that has migrated into the stomach in a patient
with a refractory benign esophageal stricture
following deployment.

Figure 1-2. Same patient as seen in Figure

1-1 undergoing removal of the migrated
stent using a rat-tooth forceps.

80%. The rate of stent migration in this study was low at 6.6%.15 In another early study
investigating the use of the Polyflex stent for benign esophageal disease in 21 patients
(17 patients with benign esophageal strictures and 4 patients with esophageal fistulae),
technical success was 100% and clinical success was 80%. However, the migration rate
was alarmingly high at 57.1%.16
More recent data on the Polyflex stent for benign esophageal disease have contin-
ued to demonstrate high rates of technical success but lower rates of clinical success
and high rates of stent migration. In a prospective study of 40 patients with refractory
benign esophageal strictures treated with the Polyflex stent by Dua et al, the clini-
cal success rate was lower than in earlier studies (40%). Complications included stent
migration in 22%, and there was one death from massive bleeding due to stent erosion
Esophageal Stents in Benign Disease 5

into a major vessel.17 In another study of 30 patients with benign esophageal disease
(8 patients had stents for benign refractory strictures, 11 for anastomotic strictures,
5 for radiation induced strictures, and the remainder for fistulae/leaks; some patients
may have had multiple indications for their stent and this is not clearly identified in the
original manuscript) by Holm et al, unacceptably low rates of symptom relief (6%) and
high rates of overall stent migration (81%) were observed. In this study, stent migration
was more frequent in proximally and distally deployed stents (68.1% and 70.4% migra-
tion rates, respectively) and less frequent with stents deployed in the midesophagus
(30%). Interestingly, the etiology of the stricture influenced migration rates as well.
Anastomotic strictures were noted to have a stent migration rate of 75% while radiation-
related strictures had lower migration rates (28.6%). This difference may be explained
in part by the length of stricture because anastomotic strictures tend to be shorter,
thereby contributing to higher rates of stent migration.18 In another recent study by Oh
et al involving 13 patients with benign refractory esophageal strictures, there was a low
clinical success rate (23%) and high migration rate (30%).19 With regard to the overall
efficacy and safety of SEPS placement for benign refractory esophageal strictures, a
systematic review of 10 studies and 130 patients by Repici et al demonstrated an overall
technical success rate of 98%, an overall clinical success rate of 52%, and an overall rate
of early stent migration (less than 4 weeks) of 24%. Excluding migration as a complica-
tion, there was still an overall complication rate of 9% with one death (0.8%).20

Partially Covered Self-Expanding Metal Stents and

Refractory Benign Esophageal Strictures
PCSEMS have been studied in the treatment of benign esophageal disease. Their use
has been limited by difficulty of stent removal and high complication rates. Partially cov-
ered stents that are readily available include the Wallflex and older generation Ultraflex
stents (both from Boston Scientific). These stents tend to be more difficult to remove
due to tissue embedment along the uncovered proximal and distal portions of the stent.
Furthermore, these stents are associated with new stricture formation secondary to gran-
ulation tissue at the ends of these stents.
In an early study of 8 patients treated with PCSEMS for benign esophageal disease,
4 patients (50%) had major complications. Two patients developed strictures above the
stent, one patient had stent migration, and one patient died of exsanguination from
stent erosion into the aorta.21 In another study of 29 patients who had PCSEMS placed
for benign esophageal strictures, new stricture formation was seen in 41%, stent migra-
tion in 31%, chest pain or worsened reflux occurred in 21%, and tracheoesophageal
fistula developed in 6% of patients.22 Given these high complication rates, PCSEMS
are, in general, not recommended for use in patients with benign refractory esophageal
strictures.

Fully Covered Self-Expanding Metal Stents and Refractory

Benign Strictures
Recently, FCSEMS have been developed to address the limitations of PCSEMS.
While removability has been enhanced, there are higher rates of migration with
FCSEMS. The Alimaxx-E esophageal stent is the best studied FCSEMS for treatment of
6 Chapter 1

Figure 1-3. Endoscopic image of an esophageal

ulcer seen following removal of a FCSEMS in
a patient with a refractory benign esophageal
stricture.

refractory benign esophageal strictures. This stent is made of nitinol, is fully covered with
a polyurethane covering, and is available in several diameters and lengths. Unlike SEPS,
FCSEMS are preloaded on a delivery system that does not require assembly prior to stent
deployment, making them somewhat easier to deploy. Also, the delivery systems for FCSEMS
are thinner and can more easily traverse tight strictures. The shaft of the stent comes in
18 and 22 mm diameters. The proximal flare is 5 mm greater than the shaft diameter (23 and
27 mm, respectively). The distal flare is 3 mm greater than the shaft diameter (21 mm and
25 mm, respectively). Available lengths for this stent are 7, 10, and 12 cm. Ideally, the stent
is deployed with 1 to 2 cm of stent length placed proximal and distal to the ends of the
stricture. The stent has a blue knotted string that is attached circumferentially to the prox-
imal flange of the stent and can be grasped using a rat-tooth forceps. When gentle pulling
traction is applied to this knot, it acts as a “purse string” and changes the configuration of
the stent from a cylinder to a cone, allowing for relatively easier removal and reposition-
ing of the stent. Removal of this stent is usually accomplished using a therapeutic upper
endoscope with forceps. A double-channel endoscope can allow removal using 2 forceps
simultaneously. Other removal techniques include using a combination of a snare and a
rat-tooth forceps.23
Several studies have evaluated the use of this stent in the treatment of refractory
benign esophageal strictures. In an early study by Eloubeidi et al, 7 patients with refrac-
tory benign esophageal strictures were treated with the Alimaxx-E stent. Symptomatic
relief of dysphagia was seen in 29% of patients with a stent migration rate of 36%. In
this study, all placed stents were successfully removed. Eighty-two percent of the stents
placed were considered easy to remove, while 18% of stents were moderately difficult
to difficult to remove. Fifty percent of the patients in this study developed ulceration
at the distal end of this stent, and 23% of patients developed ulcers along the proximal
edge of the stent, all of which resolved with stent removal (Figure 1-3). Four patients in
this study developed pseudopolyps at either the proximal or distal edge of the stent, and
2 patients were noted to have severe tissue reaction. These findings resolved after stent
removal.23
Esophageal Stents in Benign Disease 7

Figure 1-4. Endoscopic image of a fully

covered Alimaxx-ES stent in a patient with
a refractory benign esophageal stricture.
(Reprinted with permission of Douglas G.
Adler, MD.)

Figure 1-5. Fluoroscopic image of a fully

covered Wallflex stent in a patient with a
long distal esophageal benign stricture.
(Reprinted with permission of Douglas G.
Adler, MD.)

Subsequent studies involving the use of this stent in the treatment of benign refractory
esophageal strictures have demonstrated migration rates that range from 37% to 50% and
dysphagia relief in 21% to 100% of patients.24-26 Stents were easily removed in each of
these studies. Rarely, issues with stent fracture during retrieval were encountered.
Recently, a newer version of this stent, the Alimaxx-ES stent, has been developed
(Figure 1-4). In addition to the polyurethane covering, the stent has a silicone lining and
antimigration struts. Additionally, this stent is available in smaller shaft diameters (12,
14, and 16 mm) than previously available stents. There are currently no published reports
on the use of this stent in the treatment of refractory benign esophageal strictures. The
fully covered Wallflex stent is also available (Figure 1-5); however, there are no published
reports at this time on the use of this stent in the treatment of refractory benign esopha-
geal strictures.
8 Chapter 1

Figure 1-6. Fluoroscopic image of a fully covered Wallflex

stent in good position following placement in a patient
with a long segment refractory benign esophageal
stricture.

Figure 1-7. Same patient as Figure 1-6 show-

ing distal migration of the stent several weeks
following deployment.

Comparisons of Self-Expanding Plastic Versus Metal Stents

for Benign Refractory Strictures
When comparing SEPS and FCSEMS for the treatment of benign refractory esopha-
geal strictures, they are comparable with regard to migration rates and rates of clinical
success/dysphagia relief. Migration rates for SEPS range from 6.6% to 80%. Migration
rates for FCSEMS range from 36% to 50% (Figures 1-6 and 1-7). Clinical success rates for
SEPS range from 6% to 90%. Clinical success rates for FCSEMS range from 21% to 100%
(Tables 1-3 and 1-4).
A meta-analysis by Thomas et al reviewed 8 studies with a total of 199 patients
treated with self-expanding removable stents (Polyflex and nitinol SEMS) for benign
Esophageal Stents in Benign Disease 9

Table 1-3. Studies of Self-Expanding Plastic Stents (Polyflex Stent) for Benign
Esophageal Strictures

Clinical
Study N (patients) Migration Rate
Success

Oh et al19 13 30% 23%

Holm et al18 8 (benign) 81% (benign) 6% (overall)
11 (anastomotic) 75% (anastomotic)
Dua et al17 40 22% 40%
Karbowski et al40 19 30% 90%

Evrard et al16 17 57% 80%

Repici et al15 15 6.6% 80%

Table 1-4. Studies of Fully Covered Self-Expanding Metal Stents and Refractory Benign
Strictures

Migration Clinical
Study N Stent Type
Rate Success
Eloubeidi et al26 19 Alimaxx-E 37% 21%
Senousy et al25 14 Alimaxx-E 39% 100%
Bakken et al24 7 Alimaxx-E 50% 71%
Eloubeidi et al23 7 Alimaxx-E 36% 29%

esophageal strictures. The overall efficacy of self-expanding removable stents was 46.2%
with a migration rate of 26.4%.27 Comparison of dysphagia improvement for Polyflex
stents versus nitinol stents in this study favored Polyflex stents (55.3% versus 21.8%, p =
0.019). It should be noted that 6 of the 8 studies in this analysis were studies in which the
Polyflex stent was used, and none of the studies involving nitinol stents included recent
data on FCSEMS.

Biodegradable Stents
Biodegradable stents have recently been developed for use in the management of benign
esophageal strictures. The ELLA Biodegradable Stent (ELLA-CS, Hradec Kralove, Czech
Republic) is made of a biodegradable polymer, polydioxanone, that dissolves and is reab-
sorbed within 2 to 3 months after deployment. The stent itself is radiotransparent and has
radio-opaque markers at both ends. The stent has a shaft diameter of 25 mm and ranges
in length from 6 to 13.5 cm. The stent is loaded onto a 9-mm delivery catheter with a
dilator tip.
10 Chapter 1

A recent study using the ELLA Biodegradable Stent in 21 patients with refractory benign
esophageal strictures was notable for a significant decrease between pre- and poststenting
dysphagia scores (3 versus 1, p < 0.01) at a median of 53 weeks follow up. Forty-five percent
of patients in this study were dysphagia-free at the end of this study. A lower migration
rate was seen with this stent (9.5%) when compared to previously published data for SEPS
and FCSEMS. No major complications occurred; however, 3 patients were noted to have
severe chest pain postprocedure and 1 patient was noted to have minor bleeding post-
procedure. More data are needed regarding this stent before it can be recommended for
widespread clinical use in patients with refractory benign esophageal strictures.28

Technical Considerations for Placement of Esophageal Stents

for Refractory Benign Esophageal Strictures
As part of the preprocedure evaluation for patients being considered for esophageal
stent placement, one should confirm that the patient truly has a refractory benign
stricture and that adequate dilation therapy has been attempted, possibly including
appropriate adjunctive therapies to dilation, such as intralesional corticosteroid injec-
tion.
Endoscopic measurements of the luminal diameter and the location of the proxi-
mal and distal aspects of the stricture should be noted to gain a sense of the stricture’s
length and degree of complexity. If the luminal diameter is narrower than the stent
delivery catheter, then appropriate esophageal dilation should be performed prior to
stent deployment.
Ideally, the proximal aspect of a stent should be 2 to 3 cm distal to the upper esophageal
sphincter to avoid issues of airway compromise, but this is not always possible. In patients
where accurate measurements are not available, a barium esophagram can sometimes be
helpful in delineating the stricture prior to therapy.
The location of the distal aspect of the stricture in relation to the gastroesophageal (GE)
junction should also be noted. As increased rates of migration are seen with stents that
traverse the GE junction, a larger diameter stent should be considered for distal strictures.
The patient should be properly positioned for fluoroscopy for stent placement.
Orienting the patient supine can make fluoroscopic imaging easier. Fluoroscopic marking
of the proximal and distal aspects of the stricture along with the upper esophageal and
lower esophageal sphincter can be made on scope withdrawal with a guidewire in place
by external placement of paper clips affixed to the patient’s skin with tape (Figure 1-8).
Alternative approaches include recognition of nearby anatomic landmarks (ribs, vertebral
bodies, etc) to denote the proximal and distal end of the stricture, injection of fluoroscopi-
cally visible solutions such as lipiodiol, or endoscopic placement of clips at the proximal
and distal aspects of the stricture.
Esophageal stent deployment is typically performed under fluoroscopic guidance,
allowing visualization of the stent deployment in real time. While a stent can be
deployed under endoscopic guidance, endoscopic visualization alone does not allow for
visualization of the distal deployment of the stent. Alternatively, a stent can be deployed
under simultaneous endoscopic and fluoroscopic guidance. Simultaneous endo-
scopic and fluoroscopic guidance during deployment may not add much to the overall
visualization over fluoroscopy alone, but in some situations this can be helpful. Gentle
Esophageal Stents in Benign Disease 11

Figure 1-8. Fluoroscopic marking of the desired proxi-

mal end of a SEPS via the use of an external marker, in
this case, a paper clip.

neck extension can facilitate passage of the stent delivery system. This is particularly
true for the Polyflex stent, which has a larger and stiffer delivery catheter. Careful and
steady communication between the endoscopist and assistant is critical during stent
deployment to ensure proper placement of the stent. Once the stent is deployed, the
endoscope is typically reintroduced to confirm positioning of the stent and reposition-
ing can be performed if needed.
Patients typically experience pain after stent deployment (so common is this find-
ing that some do not consider this to be a “complication” as much as an expected “side
effect”). This is particularly true for Polyflex stent placement and usually subsides
within 72 hours of placement. With Polyflex stent placement, it is our practice to
admit patients for postprocedure observation and to receive adequate analgesia with
subsequent discharge the following day. If a patient develops signs of airway obstruc-
tion or stridor, intra- or postprocedurally, the stent should be removed immediately
if possible or an airway stent should be placed simultaneously to esophageal stent
placement.
For patients with distal strictures, worsening heartburn and other GERD symptoms
may be seen, and these patients are maintained on PPI therapy. Of note, newer stents are
being designed with antireflux valves to address this issue.
Stents that are placed for benign indications are typically removed 4 to 6 weeks fol-
lowing initial placement. We often obtain a chest x-ray prior to removal to confirm the
presence and position of the stent. If the stricture appears to have improved/resolved on
subsequent endoscopic evaluation, the patient is given a trial of “stent-free” existence.
For patients who continue to have persistence of their stricture, the stent can be replaced
and possibly upsized if appropriate. Patients are advised to seek medical attention if they
develop chest pain, fever, or worsening dysphagia.
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