EBD RCT Trial in Living Donor Liver Transplantation

Not Applicable

Recruiting

• Conditions: Liver Transplantation; Liver Transplant; Complications; Bile Stricture; Bile Leakage From Biliary Anastomosis
• Interventions: Procedure: External biliary drainage

• Registration Number: NCT04622540
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Study Start: 2020-12-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12
• Primary Completion: 2024-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Living donor liver transplantation
• Adult patient (>=18 years old)
• Patients who are available for at least 3 year follow-up after LDLT

Exclusion Criteria

• Patients requring hepaticojejunostomy due to anatomical factor or underlying disease
• Re-transplantation
• Multiorgan transplantation
• Emergency transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	External biliary drainage	Application of external biliary drainage

Primary Outcome Measures

Name	Time	Method
Incidence of biliary complication within 1 year after LDLT	1 year	Biliary stricture/leakage

Secondary Outcome Measures

Name	Time	Method
Patient survival	3 year	Patient survival after LDLT
Graft survival	3 year	Survival of liver graft
Complication associated with external biliary drainage	3 year	Dislocation, retraction, reposition, leakage through tube site, hemorrhage
Patient-reported outcome	3 year	Questionnaire survey
Incidence of biliary complication within 3 year after LDLT	3 year	Biliary stricture/leakage

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of