Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study

Abstract

Background: Recently, placement of fully covered self-expandable metal stents (FCSEMSs) has been proposed as an alternative treatment for the management of benign binary strictures. However, the major limitations of FCSEMSs are frequent migration and removal complications. Objective: We conducted this study to compare the antimigration effects, complication rates, and short-term efficacy of 2 FCSEMSs with either an anchoring flap (AF) or a flared end (FE) at the proximal end of the stent. Design: A multicenter, prospective comparative pilot study. Setting: Two tertiary referral centers. Patients: A total of 43 patients with benign binary stricture who were candidates for placement of FCSEMSs were assigned to the AF (n = 22) or the FE group (n = 21). Interventions: Predefined duration of placement and removal of FCSEMSs. Results: After a median period of placement of 6 months (interquartile range 4-6), no patients in the AF group and 33% of patients (7 of 21, 1 in proximal and 6 in distal) in the FE group had stent migration (P = .004). The removal rate of the FCSEMSs was 100% in both groups (per protocol, n = 22 in the AF group and n = 17 in the FE group). Immediate improvement of binary stricture was 91% (20/22, per protocol) in the AF group and 88% (15/17, per protocol) in the FE group. All stents were removed without difficulty. Limitations: Short-term follow-up after the removal of FCSEMSs. Conclusions: With regard to the antimigration effect of FCSEMSs for benign biliary stricture, the AF design may be superior to the FE. For up to 6 months, both FCSEMSs can be endoscopically removed without complications. (Clinical trial registration number: NCT00945516.) (Gastrointest Endosc 2011;73:64-70.)