NCT04622540

EBD RCT Trial in Living Donor Liver Transplantation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to demonstrate incidence of biliary complication rates after living donor liver transplantation according to the implantation of external biliary drainage throug duct-to-duct anastomosis site.

Detailed description

Biliary complication is the most common complications after liver transplantation, and it happens more often after living donor liver transplantation (LDLT) than deceased donor liver transplantation. Many transplant centers adopted their own methods to improve biliary complications after LDLT. One suggested method is the application of external biliary drainage (EBD). A prospective study was planned to demonstrate effect of EBD on biliary complication after LDLT. Patients who underwent LDLT with duct-to-duct anastomosis will be randomly assinged to application of EBD or conventional duct-to-duct anastomosis without EBD according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two groups. Primary outcome is biliary complication incidence 1 year after LDLT.

Conditions

• Liver Transplantation
• Liver Transplant; Complications
• Bile Stricture
• Bile Leakage From Biliary Anastomosis

Interventions

Type	Name	Description
PROCEDURE	External biliary drainage	Application of external biliary drainage through duct-to-duct anastomosis

Timeline

• Start date: 2020-12-09
• Primary completion: 2024-11-01
• Completion: 2026-11-01
• First posted: 2020-11-10
• Last updated: 2022-05-12

Locations

1 site across 1 country: South Korea