EBD RCT Trial in Living Donor Liver Transplantation

May 11, 2022 updated by: Suk Kyun Hong, Seoul National University Hospital

A Prospective Randomized Controlled Trial for Application of External Biliary Drainage 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Suk Kyun Hong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Suk Kyun Hong, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2020

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2026

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUHLT_EBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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