A Prospective Randomized Controlled Trial for External Biliary Drainage in Living Donor Liver Transplantation

What this Trial Is About

This research aims to evaluate the rate of biliary complications after living donor liver transplantation (LDLT), focusing on the use of external biliary drainage (EBD) through duct-to-duct anastomosis. Biliary complications are common after liver transplants and occur more frequently in living donor cases compared to deceased donor transplants. The study compares the effect of EBD against conventional duct-to-duct anastomosis methods, including the use or non-use of internal stents. Participants who receive LDLT with duct-to-duct anastomosis will be randomly assigned in equal groups to either receive external biliary drainage or undergo the conventional procedure without EBD. The study involves two groups: one with the application of EBD and the other with conventional duct-to-duct anastomosis. This randomized controlled trial is designed to monitor outcomes over several years. During the study, researchers will track biliary complication rates within one year as the primary outcome, with additional follow-up over three years to assess longer-term complications, graft survival, patient survival, and patient-reported outcomes. Participants are expected to be available for at least three years after the transplant for follow-up assessments. The study is sponsored by Seoul National University Hospital and does not involve masking or blinding.

EBD RCT Trial in Living Donor Liver Transplantation