A Randomized Controlled Trial Comparing Early Outcomes Following Duct-duct Biliary Anastomosis With or Without Transanastomotic Biliary Stenting in Adult Whole Liver Transplant Patients.

Background: Despite advances in liver transplantation, the rate of anastomotic biliary complications (ACs) remains unchanged. In the event of a biliary stricture or bile leak after duct-duct reconstruction, endoscopic retrograde biliary stenting is recognized as first-line treatment. Data on prophylactic biliary stenting performed at the time of the biliary anastomosis are conflicting. The aim of this study was to compare early AC in liver transplant recipients undergoing duct-duct reconstruction, who were randomly assigned to receive either a biliary stent (control) or no biliary stent (treatment). Methods: A single-blinded, randomized controlled, noninferiority trial with parallel treatment arms was conducted. Only patients receiving whole adult liver allografts from brain-dead donors were included. ACs included biliary stricture, bile leak, and endoscopic retrieval of retained stents from patients in the control arm. After the exclusion of patients by a priori defined criteria, 84 patients were randomly assigned to equal control and treatment arms. Results: A total of 161 adult liver transplants occurred between March 2019 and May 2022 at a single institution. The AC rate was 18% (n = 15), all of which were strictures. All ACs were managed with endoscopic retrograde biliary stenting. There was no difference in ACs between the stent and no-stent groups, but 41% of patients (n = 16) in the stented group required endoscopic removal of retained stents at 4 wk posttransplant. Conclusions: There was no difference in the rate of AC between patients who received a prophylactic biliary stent and those who did not. However, a significant number of stented patients required intervention for stent removal.