A Prospective Randomized Controlled Trial for Application of External Biliary Drainage in Living Donor Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Incidence of biliary complication within 1 year after LDLT
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental group
Application of external biliary drainage
Intervention: External biliary drainage (Procedure)
Control group
Conventional duct-to-duct anastomosis (with or without internal stent)
Outcomes
Primary Outcomes
Incidence of biliary complication within 1 year after LDLT
Time Frame: 1 year
Biliary stricture/leakage
Secondary Outcomes
- Patient survival(3 year)
- Graft survival(3 year)
- Complication associated with external biliary drainage(3 year)
- Patient-reported outcome(3 year)
- Incidence of biliary complication within 3 year after LDLT(3 year)
Investigators
Suk Kyun Hong
Clinical Assistant Professor
Seoul National University Hospital