EBD RCT Trial in Living Donor Liver Transplantation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Transplantation, Liver Transplant; Complications, Bile Stricture, Bile Leakage From Biliary Anastomosis

Intervention / Treatment
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* Procedure: External biliary drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Application of external biliary drainage | Procedure: External biliary drainage<br>* Application of external biliary drainage through duct-to-duct anastomosis<br>|
| No Intervention: Control group<br>Conventional duct-to-duct anastomosis (with or without internal stent) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biliary complication within 1 year after LDLT | Biliary stricture/leakage | 1 year | 

Secondary Outcome Measures

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