Fully Covered Self-Expandable Metal Stent with an Anti-Migration System Vs Plastic Stent for Distal Biliary Obstruction Caused by Borderline Resectable Pancreatic Cancer

Abstract Background and aim: Biliary obstruction can impair the effectiveness of neo-adjuvant chemotherapy. This study was designed to compare biliary stenting with covered self-expandable metal stents (FCSEMS) and plastic stents (PS) in patients with biliary obstruction caused by borderline resectable pancreatic cancer (BRPC) who were undergoing neo-adjuvant chemotherapy during preoperative biliary drainage. Methods: This single-center, comparative, randomized, superiority study was designed to compare FCSEMS with PS for drainage of biliary obstruction of BRPC. Twenty two eligible patients providing informed consent will be randomized 1:1 by computer to either FCSEMS or PS for endoscopic retrograde biliary drainage (ERBD). All subsequent clinical interventions, including crossover to alternative procedures, will be at the discretion of the treating physician based on standard clinical care. The primary outcomes will be the rates and causes of stent dysfunction during preoperative biliary drainage. Other outcomes include time required for ERBD, adverse events related to ERBD, period from ERBD to surgery, percentage of patients able to undergo surgery, operation time, intraoperative bleeding volume, postoperative adverse events, and postoperative hospitalization. Subjects, treating clinicians, and outcome assessors will not be blinded to assignment. Discussion: This study is intended to determine whether FCSEMS or PS is the better biliary stent for ERBD for management of patients with biliary obstruction of BRPC, a common clinical dilemma that has not yet been investigated in randomized trials. Trials registration: UMIN-CTR, Identifier: UMIN000030473. Registered July 10, 2017, Wakayama Medical University Hospital.