NCT04139473

Brief Summary

The scarcity of deceased donor organ supply has driven the practice of living donor liver transplantation (LDLT). Right lobe LDLT (RLDLT) has developed over the last 10 years to extend the benefit of LDLT to adult patients. With technical refinement, the results have significantly improved but bile duct complications remain the Achilles heel that affects the recipient's long-term outcome.Hepaticojejunostomy (HJ) was originally the standard technique for bile duct reconstruction in RLDLT but in recent years, duct-to-duct anastomosis (DDA) has been adopted by most transplant centers. The advantages of duct-to-duct reconstruction include a shorter operation time, less infection complications, more physiologic enteric functions and easier endoscopic access to the biliary tract but bile duct complication, particularly stricture is the major concern. The development of stricture is likely to be related to the blood supply of the anastomosis. We hypothesize that HJ has a better blood supply and is associated with a lower overall bile duct complication rate than duct-to-duct anastomosis. We propose a randomized trial to test this hypothesis and to compare various outcome measures between HJ and duct-to-duct reconstruction. The results of the study will set the standard for the technique of biliary reconstruction in RLDLT and will further advance this procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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 Start

First participant enrolled

May 15, 2012

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

10.6 years

First QC Date

October 9, 2019

Last Update Submit

October 24, 2019

Conditions

Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Biliary complications

    Compare all biliary-associated complications after operation including leakage and stricture

    5 years

Secondary Outcomes (4)

  • Operative time for liver transplantation

    intraoperative

  • Gastrointestinal function after liver transplantation

    5 years

  • Hospital stay after liver transplantation

    5 years

  • Chances of re-intervention

    5 years

Study Arms (2)

Hepaticojejunostomy

ACTIVE COMPARATOR

Patients undergo right lobe living donor liver transplantation will receive hepaticojejunostomy

Procedure: Hepaticojejunostomy / Duct-to-duct anastomosis

Duct-to-duct anastomosis

ACTIVE COMPARATOR

Patients undergo right lobe living donor liver transplantation will receive duct-to-duct anastomosis

Procedure: Hepaticojejunostomy / Duct-to-duct anastomosis

Interventions

Hepaticojejunostomy / Duct-to-duct anastomosisPROCEDURE
Duct-to-duct anastomosisHepaticojejunostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recipient age older than 18 years
  • primary transplant

You may not qualify if:

  • recipient refusal/withdrawal
  • haemodynamic instability at the time of biliary reconstruction
  • biliary reconstruction with duct-to-duct anastomosis is unsafe or technically not feasible
  • unhealthy recipient's bile duct, anatomical variant in donor's right duct
  • biliary reconstruction with hepaticojejunostomy is unsafe or technically not feasible
  • excessively edematous bowel, failure to create Roux-en-Y jejunal loop due to excessive
  • bowel adhesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (21)

  • Lo CM, Fan ST, Liu CL, Lo RJ, Lau GK, Wei WI, Li JH, Ng IO, Wong J. Extending the limit on the size of adult recipient in living donor liver transplantation using extended right lobe graft. Transplantation. 1997 May 27;63(10):1524-8. doi: 10.1097/00007890-199705270-00027.

    PMID: 9175822BACKGROUND

  • Lo CM, Fan ST, Liu CL, Wei WI, Lo RJ, Lai CL, Chan JK, Ng IO, Fung A, Wong J. Adult-to-adult living donor liver transplantation using extended right lobe grafts. Ann Surg. 1997 Sep;226(3):261-9; discussion 269-70. doi: 10.1097/00000658-199709000-00005.

    PMID: 9339932BACKGROUND

  • Wachs ME, Bak TE, Karrer FM, Everson GT, Shrestha R, Trouillot TE, Mandell MS, Steinberg TG, Kam I. Adult living donor liver transplantation using a right hepatic lobe. Transplantation. 1998 Nov 27;66(10):1313-6. doi: 10.1097/00007890-199811270-00008.

    PMID: 9846514BACKGROUND

  • Marcos A, Fisher RA, Ham JM, Shiffman ML, Sanyal AJ, Luketic VA, Sterling RK, Posner MP. Right lobe living donor liver transplantation. Transplantation. 1999 Sep 27;68(6):798-803. doi: 10.1097/00007890-199909270-00012.

    PMID: 10515380BACKGROUND

  • Trotter JF, Wachs M, Everson GT, Kam I. Adult-to-adult transplantation of the right hepatic lobe from a living donor. N Engl J Med. 2002 Apr 4;346(14):1074-82. doi: 10.1056/NEJMra011629. No abstract available.

    PMID: 11932476BACKGROUND

  • Malago M, Testa G, Frilling A, Nadalin S, Valentin-Gamazo C, Paul A, Lang H, Treichel U, Cicinnati V, Gerken G, Broelsch CE. Right living donor liver transplantation: an option for adult patients: single institution experience with 74 patients. Ann Surg. 2003 Dec;238(6):853-62; discussion 862-3. doi: 10.1097/01.sla.0000098619.71694.74.

    PMID: 14631222BACKGROUND

  • Todo S, Furukawa H, Jin MB, Shimamura T. Living donor liver transplantation in adults: outcome in Japan. Liver Transpl. 2000 Nov;6(6 Suppl 2):S66-72. doi: 10.1053/jlts.2000.19009.

    PMID: 11084089BACKGROUND

  • Bak T, Wachs M, Trotter J, Everson G, Trouillot T, Kugelmas M, Steinberg T, Kam I. Adult-to-adult living donor liver transplantation using right-lobe grafts: results and lessons learned from a single-center experience. Liver Transpl. 2001 Aug;7(8):680-6. doi: 10.1053/jlts.2001.26509.

    PMID: 11510011BACKGROUND

  • Lee SG, Park KM, Hwang S, Lee YJ, Kim KH, Ahn CS, Choi DL, Joo SH, Jeon JY, Chu CW, Moon DB, Min PC, Koh KS, Han SH, Park SH, Choi GT, Hwang KS, Lee EJ, Chung YH, Lee YS, Lee HJ, Kim MH, Lee SK, Suh DJ, Kim JJ, Sung KB. Adult-to-adult living donor liver transplantation at the Asan Medical Center, Korea. Asian J Surg. 2002 Oct;25(4):277-84. doi: 10.1016/S1015-9584(09)60192-5.

    PMID: 12470999BACKGROUND

  • Nakamura T, Tanaka K, Kiuchi T, Kasahara M, Oike F, Ueda M, Kaihara S, Egawa H, Ozden I, Kobayashi N, Uemoto S. Anatomical variations and surgical strategies in right lobe living donor liver transplantation: lessons from 120 cases. Transplantation. 2002 Jun 27;73(12):1896-903. doi: 10.1097/00007890-200206270-00008.

    PMID: 12131684BACKGROUND

  • Olthoff KM, Merion RM, Ghobrial RM, Abecassis MM, Fair JH, Fisher RA, Freise CE, Kam I, Pruett TL, Everhart JE, Hulbert-Shearon TE, Gillespie BW, Emond JC; A2ALL Study Group. Outcomes of 385 adult-to-adult living donor liver transplant recipients: a report from the A2ALL Consortium. Ann Surg. 2005 Sep;242(3):314-23, discussion 323-5. doi: 10.1097/01.sla.0000179646.37145.ef.

    PMID: 16135918BACKGROUND

  • Lo CM, Fan ST, Liu CL, Chan JK, Lam BK, Lau GK, Wei WI, Wong J. Minimum graft size for successful living donor liver transplantation. Transplantation. 1999 Oct 27;68(8):1112-6. doi: 10.1097/00007890-199910270-00009.

    PMID: 10551638BACKGROUND

  • Fan ST, Lo CM, Liu CL. Technical refinement in adult-to-adult living donor liver transplantation using right lobe graft. Ann Surg. 2000 Jan;231(1):126-31. doi: 10.1097/00000658-200001000-00018.

    PMID: 10636112BACKGROUND

  • Lo CM, Fan ST, Liu CL, Wong J. Hepatic venoplasty in living-donor liver transplantation using right lobe graft with middle hepatic vein. Transplantation. 2003 Feb 15;75(3):358-60. doi: 10.1097/01.TP.0000046527.19422.3E.

    PMID: 12589159BACKGROUND

  • Fan ST, Lo CM, Liu CL, Tso WK, Wong J. Biliary reconstruction and complications of right lobe live donor liver transplantation. Ann Surg. 2002 Nov;236(5):676-83. doi: 10.1097/00000658-200211000-00019.

    PMID: 12409675BACKGROUND

  • Lo CM, Fan ST, Liu CL, Yong BH, Wong Y, Lau GK, Lai CL, Ng IO, Wong J. Lessons learned from one hundred right lobe living donor liver transplants. Ann Surg. 2004 Jul;240(1):151-8. doi: 10.1097/01.sla.0000129340.05238.a0.

    PMID: 15213631BACKGROUND

  • Liu CL, Lo CM, Chan SC, Fan ST. Safety of duct-to-duct biliary reconstruction in right-lobe live-donor liver transplantation without biliary drainage. Transplantation. 2004 Mar 15;77(5):726-32. doi: 10.1097/01.tp.0000116604.89083.2f.

    PMID: 15021836BACKGROUND

  • 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

  • Yi NJ, Suh KS, Cho JY, Kwon CH, Lee KU. In adult-to-adult living donor liver transplantation hepaticojejunostomy shows a better long-term outcome than duct-to-duct anastomosis. Transpl Int. 2005 Nov;18(11):1240-7. doi: 10.1111/j.1432-2277.2005.00209.x.

    PMID: 16221154BACKGROUND

  • Ishiko T, Egawa H, Kasahara M, Nakamura T, Oike F, Kaihara S, Kiuchi T, Uemoto S, Inomata Y, Tanaka K. Duct-to-duct biliary reconstruction in living donor liver transplantation utilizing right lobe graft. Ann Surg. 2002 Aug;236(2):235-40. doi: 10.1097/00000658-200208000-00012.

    PMID: 12170029BACKGROUND

  • Grewal HP, Shokouh-Amiri MH, Vera S, Stratta R, Bagous W, Gaber AO. Surgical technique for right lobe adult living donor liver transplantation without venovenous bypass or portocaval shunting and with duct-to-duct biliary reconstruction. Ann Surg. 2001 Apr;233(4):502-8. doi: 10.1097/00000658-200104000-00004.

    PMID: 11303131BACKGROUND

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

Kenneth Chok, MBBS

CONTACT

22553025chok6275@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 25, 2019

Study Start

May 15, 2012

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)