Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04622540

EBD RCT Trial in Living Donor Liver Transplantation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Suk Kyun Hong

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External biliary drainage

Procedure

Application of external biliary drainage through duct-to-duct anastomosis

Primary outcomes

  1. Incidence of biliary complication within 1 year after LDLT

    Time frame: 1 year

    Biliary stricture/leakage

Secondary outcomes

  1. Incidence of biliary complication within 3 year after LDLT

    Time frame: 3 year

    Biliary stricture/leakage

  2. Complication associated with external biliary drainage

    Time frame: 3 year

    Dislocation, retraction, reposition, leakage through tube site, hemorrhage

  3. Graft survival

    Time frame: 3 year

    Survival of liver graft

  4. Patient survival

    Time frame: 3 year

    Patient survival after LDLT

  5. Patient-reported outcome

    Time frame: 3 year

    Questionnaire survey

Study contacts

Contact information is provided by the study sponsor or research team.

Su young Hong, MD

CONTACT

[email protected]

+82-2-2072-2326

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Nov 10, 2020
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.