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EBD RCT Trial in Living Donor Liver Transplantation

Recruiting
19 - 79 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

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

NCT04622540

Seoul National University Hospital

25 January 2024

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