Treatment of post-cholecystectomy biliary strictures with fully-covered self-expanding metal stents - results after 5 years of follow-up

Andrea Tringali, D Nageshwar Reddy, Thierry Ponchon, Horst Neuhaus, Ferrán González-Huix Lladó, Claudio Navarrete, Marco J Bruno, Paul P Kortan, Sundeep Lakhtakia, Joyce Peetermans, Matthew Rousseau, David Carr-Locke, Jacques Devière, Guido Costamagna, Benign Biliary Stenoses Working Group, Andrea Tringali, D Nageshwar Reddy, Thierry Ponchon, Horst Neuhaus, Ferrán González-Huix Lladó, Claudio Navarrete, Marco J Bruno, Paul P Kortan, Sundeep Lakhtakia, Joyce Peetermans, Matthew Rousseau, David Carr-Locke, Jacques Devière, Guido Costamagna, Benign Biliary Stenoses Working Group

Abstract

Background: Endoscopic treatment of post-cholecystectomy biliary strictures (PCBS) with multiple plastic biliary stents placed sequentially is a minimally invasive alternative to surgery but requires multiple interventions. Temporary placement of a single fully-covered self-expanding metal stent (FCSEMS) may offer safe and effective treatment with fewer re-interventions. Long-term effectiveness of treatment with FCSEMS to obtain PCBS resolution has not yet been studied.

Methods: In this prospective multi-national study in patients with symptomatic benign biliary strictures (N = 187) due to various etiologies received a FCSEMS with scheduled removal at 6-12 months and were followed for 5 years. We report here long-term outcomes of the subgroup of patients with PCBS (N = 18). Kaplan Meier analyses assessed long-term freedom from re-stenting. Adverse events were documented.

Results: Endoscopic removal of the FCSEMS was achieved in 83.3% (15/18) of patients after median indwell of 10.9 (range 0.9-13.8) months. In the remaining 3 patients (16.7%), the FCSEMS spontaneously migrated and passed without complications. At the end of FCSEMS indwell, 72% (13/18) of patients had stricture resolution. At 5 years after FCSEMS removal, 84.6% (95% CI 65.0-100.0%) of patients who had stricture resolution at FCSEMS removal remained stent-free. In addition, at 75 months after FCSEMS placement, the probability of remaining stent-free was 61.1% (95% CI 38.6-83.6%) for all patients. Stent or removal related serious adverse events occurred in 38.9% (7/18) all resolved without sequalae.

Conclusions: In patients with symptomatic PCBS, temporary placement of a single FCSEMS intended for 10-12 months indwell is associated with long-term stricture resolution up to 5 years. Temporary placement of a single FCSEMS may be considered for patients with PCBS not involving the main hepatic confluence.

Trial registration numbers: NCT01014390; CTRI/2012/12/003166; Registered 17 November 2009.

Keywords: Benign biliary stricture; Cholecystectomy; V fully-covered self-expanding metal stents.

Conflict of interest statement

Dr. Tringali has no conflicts of interest or financial ties to disclose.

Dr. Reddy has no conflicts of interest or financial ties to disclose.

Dr. Ponchon reports grants from Boston Scientific, during the conduct of the study; personal fees from Olympus Company, personal fees from Boston Scientific, grants and personal fees from Norgine, personal fees from Fujifil, personal fees from Ipsen, outside the submitted work.

Dr. Neuhaus reports receiving honorarium for consulting and speaking for Boston Scientific.

Dr. González-Huix Lladó reports other from Boston Scientific, during the conduct of the study; other from null, outside the submitted work.

Dr. Navarrete reports reports grants from Boston Scientific Corporation, during the conduct of the study.

Dr. Bruno reports grants from Boston Scientific, grants from Cook Medical, grants from 3 M, grants from Pentax Medical, personal fees from Boston Scientific, personal fees from Cook Medical, personal fees from 3 M, personal fees from Pentax Medical, personal fees from Mylan, personal fees from SOCAR, outside the submitted work.

Dr. Kortan reports grants from Boston Scientific Corporation, during the conduct of the study.

Dr. Lakhtakia has no conflicts of interest or financial ties to disclose.

Dr. Peetermans is an employee of Boston Scientific Corporation, the sponsor of this study.

Dr. Carr-Locke reports other from Steris Corporation, other from Telemed Systems, other from Boston Scientific Corporation, outside the submitted work.

Dr. Devière reports receiving Research support for IRB approved studies: Boston Scientific, Cook medical, Olympus, Fractyl, and Endotools, outside the submitted work.

Mr. Rousseau is an employee of Boston Scientific Corporation, the sponsor of the study.

Dr. Costamagna reports grants from Cook Endoscopy, grants from Olympus, grants from Boston Scientific, grants from Tae Woong, during the conduct of the study.

Figures

Fig. 1
Fig. 1
A 10 mm diameter Fully Covered Self-Expandable Metal Stent corresponds to seven 10 Fr plastic stents
Fig. 2
Fig. 2
a Cholangiogram showing a post cholecystectomy stricture at > 2 cm from the main hepatic confluence near the laparoscopic clips (arrow). b Fully Covered Wallflex stent is deployed. c Stricture resolution (arrow) after Wallflex removal
Fig. 3
Fig. 3
Patient flowchart. The flowchart shows occurrence of post-cholecystectomy biliary strictures resolution after FCSEMS removal and the stricture recurrence at 5 years follow-up in the 13 cases with initial stricture resolution
Fig. 4
Fig. 4
Independent variables by post-cholecystectomy biliary strictures resolution at FCSEMS removal. Univariate Forest Plot of Stricture Resolution at Removal
Fig. 5
Fig. 5
Independent variables by post-cholecstectomy biliary strictures recurrence after initial resolution at FCSEMS removal. Univariate Forest Plot of Stricture Recurrence after Resolution
Fig. 6
Fig. 6
Kaplan-Meier analysis of freedom from post-cholecystectomy biliary strictures recurrence in patients who had stricture resolution at FCSEMS removal. At 60 months after FCSEMS removal, 84.6% (95% CI 65.0–100%) of patients who had stricture resolution at FCSEMS removal remained stent-free
Fig. 7
Fig. 7
Kaplan-Meier analysis of freedom from restenting in all patients treated for post-cholecystectomy biliary strictures. At 75 months after FCSEMS placement, 61.1% (95% CI 38.6–83.6%) of patients who had FCSEMS placement for treatment of PCBS remained stent-free

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