NCT04622540

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Dec 2020Nov 2026

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

December 9, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

3.9 years

First QC Date

November 4, 2020

Last Update Submit

May 11, 2022

Conditions

Liver TransplantationLiver Transplant; ComplicationsBile StrictureBile Leakage From Biliary Anastomosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of biliary complication within 1 year after LDLT

    Biliary stricture/leakage

    1 year

Secondary Outcomes (5)

  • Incidence of biliary complication within 3 year after LDLT

    3 year

  • Complication associated with external biliary drainage

    3 year

  • Graft survival

    3 year

  • Patient survival

    3 year

  • Patient-reported outcome

    3 year

Study Arms (2)

Experimental group

EXPERIMENTAL

Application of external biliary drainage

Procedure: External biliary drainage

Control group

NO INTERVENTION

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

Interventions

External biliary drainagePROCEDURE

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

Experimental group

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living donor liver transplantation
  • Adult patient (\>=18 years old)
  • Patients who are available for at least 3 year follow-up after LDLT

You may not qualify if:

  • Patients requring hepaticojejunostomy due to anatomical factor or underlying disease
  • Re-transplantation
  • Multiorgan transplantation
  • Emergency transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (6)

  • 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.

    PMID: 18976306BACKGROUND

  • 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.

    PMID: 21143651BACKGROUND

  • 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.

    PMID: 16528711BACKGROUND

  • 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.

    PMID: 32387205BACKGROUND

  • 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.

    PMID: 24767322BACKGROUND

  • 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.

    PMID: 25358749BACKGROUND

Study Officials

  • Suk Kyun Hong, MD

    Seoul National University Hospital

    STUDY CHAIR

Central Study Contacts

Su young Hong, MD

CONTACT

+82-2-2072-2326sypurple@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

December 9, 2020

Primary Completion

November 1, 2024

Study Completion (Estimated)

November 1, 2026

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)