Gastroenterology

Gastroenterology

Volume 147, Issue 2, August 2014, Pages 385-395
Gastroenterology

Original Research
Full Report: Clinical—Biliary
Successful Management of Benign Biliary Strictures With Fully Covered Self-Expanding Metal Stents

https://doi.org/10.1053/j.gastro.2014.04.043Get rights and content

Background & Aims

Fully covered self-expanding metal stents (FCSEMS) are gaining acceptance for the treatment of benign biliary strictures. We performed a large prospective multinational study to study the ability to remove these stents after extended indwell and the frequency and durability of stricture resolution.

Methods

In a nonrandomized study at 13 centers in 11 countries, 187 patients with benign biliary strictures received FCSEMS. Removal was scheduled at 10–12 months for patients with chronic pancreatitis or cholecystectomy and at 4–6 months for patients who received liver transplants. The primary outcome measure was removal success, defined as either scheduled endoscopic removal of the stent with no removal-related serious adverse events or spontaneous stent passage without the need for immediate restenting.

Results

Endoscopic removal of FCSEMS was not performed for 10 patients because of death (from unrelated causes), withdrawal of consent, or switch to palliative treatment. For the remaining 177 patients, removal success was accomplished in 74.6% (95% confidence interval [CI], 67.5%–80.8%). Removal success was more frequent in the chronic pancreatitis group (80.5%) than in the liver transplantation (63.4%) or cholecystectomy (61.1%) groups (P = .017). FCSEMS were removed by endoscopy from all patients in whom this procedure was attempted. Stricture resolution without restenting upon FCSEMS removal occurred in 76.3% of patients (95% CI, 69.3%–82.3%). The rate of resolution was lower in patients with FCSEMS migration (odds ratio, 0.22; 95% CI, 0.11–0.46). Over a median follow-up period of 20.3 months (interquartile range, 12.9–24.3 mo), the rate of stricture recurrence was 14.8% (95% CI, 8.2%–20.9%). Stent- or removal-related serious adverse events, most often cholangitis, occurred in 27.3% of patients. There was no stent- or removal-related mortality.

Conclusions

In a large prospective multinational study, removal success of FCSEMS after extended indwell and stricture resolution were achieved for approximately 75% of patients. ClincialTrials.gov number, NCT01014390.

Section snippets

Design

This prospective nonrandomized clinical trial (ClinicalTrials.gov: NCT01014390) was conducted at 13 tertiary referral centers in 11 countries on 5 continents. The trial was approved by the Independent Ethics Committee at each participating center. The study objective was to determine the effectiveness and safety of FCSEMS (WallFlex Biliary RX Stent; Boston Scientific Corp, Natick, MA) in the treatment of biliary obstruction resulting from BBS. The primary study outcome measure was removal

Patients

A total of 209 patients were screened for study entry (Figure 1). FCSEMS were placed in 187 consecutive patients satisfying the study eligibility criteria and comprising groups of 127 CP patients, 42 OLT patients, and 18 CCY patients (Table 1). The median number of patients undergoing FCSEMS placement at the 13 study centers was 10 (range, 3–34 patients).

In the CP group, FCSEMS were placed a median of 28.0 months (IQR, 11.4–70.1 mo) after CP diagnosis. A median of 9.4 months (IQR, 3.6–27.2 mo)

Discussion

This prospective multinational study of BBS shows that successful endoscopic removal of FCSEMS after extended indwell and stricture resolution could be accomplished in approximately three quarters of patients. This study also shows differences in susceptibility to migration related to stricture etiology.

Because these strictures are benign, the objective is long-term stricture resolution after only temporary indwell of the stent. Thus, a prerequisite for wider use of FCSEMS is uncomplicated

Acknowledgment

The authors gratefully acknowledge the contributions of Lawrence Stein, MD (Division of Gastroenterology, McGill University Health Center, McGill University, Montréal, Québec, Canada) in the performance of endoscopic procedures, Jeremy Bolt (Boston Scientific Corp., Natick, MA) in trial coordination, Thomas Bowman, MD (Boston Scientific) in safety oversight, and John C. Evans, PhD, Matthew Rousseau, and Wen Ding (Boston Scientific), and Mahlon M. Wilkes, PhD, and Roberta J. Navickis, PhD

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    This article has an accompanying continuing medical education activity on page e15. Learning Objective: upon completion of this activity, participants should be able to discuss the indications to use self-expandable metal stents (SEMS) for management of benign biliary strictures, identify patients at high-risk and low-risk for migration of these stents after placement, and understand the risks and benefits of fully-covered, self-expandable metal stents (FCSEMS) versus plastic stents for management of chronic pancreatitis.

    Conflicts of interest These authors disclose the following: Jacques Devière has received research funding from Boston Scientific and Cook Endoscopy, and honoraria from Olympus and Taewoong Medical; Andreas Püspök has received speakers fees from Boston Scientific; Thierry Ponchon has received honoraria for consulting and teaching activities from Boston Scientific; Marco Bruno and Horst Neuhaus have acted as consultants and invited speakers for Boston Scientific; Alan Barkun has served as a consultant for Boston Scientific, Cook Endoscopy, and Olympus, and received research funding from Boston Scientific; Joyce Peetermans and Erin Leckrone are employees of Boston Scientific; and Guido Costamagna has received research funding from Boston Scientific, Cook Endoscopy, Olympus, and Taewoong Medical. The remaining authors disclose no conflicts.

    Funding Supported by Boston Scientific Corp, Natick, Massachusetts. Mahlon M. Wilkes, PhD and Roberta J. Navickis, PhD, of Hygeia Associates, Grass Valley, California, provided writing assistance with funding from Boston Scientific Corp.

    The sponsor participated in the design of the study and the collection, analysis, and interpretation of data.

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