Safety and Efficacy of a 6-Month Placement of a Fully Covered Self-Expanding Metallic Stent for Refractory Benign Biliary Stricture: A Multicenter Prospective Study.

Abstract

Background and aim: Managing benign biliary stricture endoscopically is complicated and challenging. This study aimed to evaluate the safety and efficacy of a 6-month placement of a fully covered self-expanding metallic stent for refractory benign biliary stricture.

Methods: Twenty-two patients with refractory benign biliary stricture (13 with chronic pancreatitis and 9 without) were recruited from five higher tertiary care centers. All patients received a planned 6-month fully covered self-expanding metallic stent placement. Primary outcomes included clinical success, technical success of stent removal, adverse events, and stricture recurrence.

Results: Of the 21 cases (one case was excluded owing to malignant findings), fully covered self-expanding metallic stent placement was successful in all cases, with contralateral bile duct plastic stents used in three patients and stents remaining in place for 6 months in 16 of 21 patients. Distal stent migration occurred in three cases, two of which had resolved strictures. Adverse events were observed in 19.0% of patients: one case of severe cholangitis, two cases of mild cholangitis, and one case of hyperplasia formation. No stent-induced pancreatitis or cholecystitis occurred. All stents were removed successfully, and the treatment success rate was 85%. One patient experienced recurrent stricture 6.5 months post-stent removal.

Conclusions: A six-month placement of a modified fully covered self-expanding metallic stent effectively improved strictures and minimized stent-induced Adverse events in patients with refractory benign biliary stricture.

Trial registration: UMIN ID: UMIN000025027.