EBD RCT Trial in Living Donor Liver Transplantation

NCT ID: NCT04622540

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental group

Application of external biliary drainage

Group Type EXPERIMENTAL

External biliary drainage

Intervention Type PROCEDURE

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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External biliary drainage

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Suk Kyun Hong

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suk Kyun Hong, MD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Su young Hong, MD

Role: CONTACT

+82-2-2072-2326

Facility Contacts

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Suk Kyun Hong

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21143651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18976306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16528711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32387205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24767322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25358749 (View on PubMed)

Other Identifiers

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SNUHLT_EBD

Identifier Type: -

Identifier Source: org_study_id

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