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EBD RCT Trial in Living Donor Liver Transplantation

Primary Purpose

Liver Transplantation, Liver Transplant; Complications, Bile Stricture

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
External biliary drainage
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplantation

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Application of external biliary drainage

Conventional duct-to-duct anastomosis (with or without internal stent)

Outcomes

Primary Outcome Measures

Incidence of biliary complication within 1 year after LDLT
Biliary stricture/leakage

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2020
Last Updated
May 11, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04622540
Brief Title
EBD RCT Trial in Living Donor Liver Transplantation
Official Title
A Prospective Randomized Controlled Trial for Application of External Biliary Drainage in Living Donor Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Liver Transplant; Complications, Bile Stricture, Bile Leakage From Biliary Anastomosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Application of external biliary drainage
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional duct-to-duct anastomosis (with or without internal stent)
Intervention Type
Procedure
Intervention Name(s)
External biliary drainage
Intervention Description
Application of external biliary drainage through duct-to-duct anastomosis
Primary Outcome Measure Information:
Title
Incidence of biliary complication within 1 year after LDLT
Description
Biliary stricture/leakage
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of biliary complication within 3 year after LDLT
Description
Biliary stricture/leakage
Time Frame
3 year
Title
Complication associated with external biliary drainage
Description
Dislocation, retraction, reposition, leakage through tube site, hemorrhage
Time Frame
3 year
Title
Graft survival
Description
Survival of liver graft
Time Frame
3 year
Title
Patient survival
Description
Patient survival after LDLT
Time Frame
3 year
Title
Patient-reported outcome
Description
Questionnaire survey
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Su young Hong, MD
Phone
+82-2-2072-2326
Email
sypurple@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk Kyun Hong, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suk Kyun Hong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18976306
Citation
Freise CE, Gillespie BW, Koffron AJ, Lok AS, Pruett TL, Emond JC, Fair JH, Fisher RA, Olthoff KM, Trotter JF, Ghobrial RM, Everhart JE; A2ALL Study Group. Recipient morbidity after living and deceased donor liver transplantation: findings from the A2ALL Retrospective Cohort Study. Am J Transplant. 2008 Dec;8(12):2569-79. doi: 10.1111/j.1600-6143.2008.02440.x. Epub 2008 Oct 24.
Results Reference
background
PubMed Identifier
21143651
Citation
Akamatsu N, Sugawara Y, Hashimoto D. Biliary reconstruction, its complications and management of biliary complications after adult liver transplantation: a systematic review of the incidence, risk factors and outcome. Transpl Int. 2011 Apr;24(4):379-92. doi: 10.1111/j.1432-2277.2010.01202.x. Epub 2010 Dec 10.
Results Reference
background
PubMed Identifier
16528711
Citation
Hwang S, Lee SG, Sung KB, Park KM, Kim KH, Ahn CS, Lee YJ, Lee SK, Hwang GS, Moon DB, Ha TY, Kim DS, Jung JP, Song GW. Long-term incidence, risk factors, and management of biliary complications after adult living donor liver transplantation. Liver Transpl. 2006 May;12(5):831-8. doi: 10.1002/lt.20693.
Results Reference
background
PubMed Identifier
32387205
Citation
Jung DH, Ikegami T, Balci D, Bhangui P. Biliary reconstruction and complications in living donor liver transplantation. Int J Surg. 2020 Oct;82S:138-144. doi: 10.1016/j.ijsu.2020.04.069. Epub 2020 May 5.
Results Reference
background
PubMed Identifier
24767322
Citation
Park CS, Jung BH, Hwang S, Park YH, Kang SH, Park GC, Song GW, Jung DH, Ahn CS, Kim KH, Moon DB, Ha TY, Lee SG. External biliary drainage in living donor liver transplantation using duct-to-duct anastomosis. Transplant Proc. 2014 Apr;46(3):678-81. doi: 10.1016/j.transproceed.2013.11.150.
Results Reference
background
PubMed Identifier
25358749
Citation
Lee SG. A complete treatment of adult living donor liver transplantation: a review of surgical technique and current challenges to expand indication of patients. Am J Transplant. 2015 Jan;15(1):17-38. doi: 10.1111/ajt.12907. Epub 2014 Oct 30.
Results Reference
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EBD RCT Trial in Living Donor Liver Transplantation

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