A Multi-Facility, Randomized, Comparative Study Examining the Efficacy of Biliary Reconstruction Under a Surgical Microscope in Living Donor Liver Transplantation.

Abstract

Introduction: Postoperative biliary complications in living donor liver transplantation are often difficult to treat, and if treatment is not successful, the patient's QOL is significantly reduced. The frequency of postoperative biliary complications is reported to be higher than that of deceased donor transplantation. In 2013, Lin et al. reported that while biliary reconstruction has traditionally used a surgical surgical loupe (2.5x-4.5x), biliary reconstruction using a surgical microscope (5x-15x) can reduce the incidence of complications. The objective of this study is to clarify the efficacy of biliary reconstruction using surgical microscope in living donor liver transplantation by a multi-facility, randomized comparative study.

Methods and analysis: It is an open-label randomized controlled study in which target patients who meet the registration requirements are randomly allocated to a surgical loupe group and a microscopy group after obtaining their consent (Ratio 1:1). The primary endpoint is an incidence of biliary complications (bile leakage and anastomotic biliary stricture) with Clavien-Dindo class III or higher within 52 weeks following surgery. The secondary endpoint is length of time required for biliary reconstruction using a surgical microscope.

Ethics and dissemination: This study protocol was approved by the institutional review board of Nagasaki University Hospital (No. 20122102-2). The study is registered in UMIN-CTR as UMIN000042011. Written informed consent will be obtained from all participants. The results will be published in a peer-reviewed journal and will be presented at medical meetings.

Highlights: Postoperative biliary complications in living donor liver transplantation are often difficult to treat.Lower incidence of biliary complication following biliary reconstruction using a surgical microscope has been reported.Facilities those use a surgical microscope for biliary reconstruction are limited.The first study to investigate the efficacy of surgical microscope for biliary construction in liver transplantation by randomized controlled trial.