EBD RCT Trial in Living Donor Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622540
• Other study ID #: SNUHLT_EBD
• Status: Recruiting
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: November 2026

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Su young Hong, MD
• Phone: +82-2-2072-2326
• Email: sypurple[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: November 2026
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Leakage From Biliary Anastomosis
• Bile Stricture
• Constriction, Pathologic
• Liver Transplant; Complications
• Liver Transplantation

Intervention

Procedure:
• External biliary drainage
Application of external biliary drainage through duct-to-duct anastomosis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of biliary complication within 1 year after LDLT	Biliary stricture/leakage	1 year
Secondary	Incidence of biliary complication within 3 year after LDLT	Biliary stricture/leakage	3 year
Secondary	Complication associated with external biliary drainage	Dislocation, retraction, reposition, leakage through tube site, hemorrhage	3 year
Secondary	Graft survival	Survival of liver graft	3 year
Secondary	Patient survival	Patient survival after LDLT	3 year
Secondary	Patient-reported outcome	Questionnaire survey	3 year