Original ResearchFull Report: Clinical—BiliarySuccessful Management of Benign Biliary Strictures With Fully Covered Self-Expanding Metal Stents
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.