Randomized Trial of Hepaticojejunostomy Versus Duct-to-duct Anastomosis in Right Lobe Living Donor Liver Transplantation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Kenneth Chok, MBBS
- Phone Number: 085228592111 22553025
- Email: chok6275@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- Queen Mary Hospital
-
Contact:
- Kenneth Chok, MBBS
- Phone Number: 085222553025 085222553025
- Email: chok6275@hku.hk
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- recipient age older than 18 years
- primary transplant
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Hepaticojejunostomy
Patients undergo right lobe living donor liver transplantation will receive hepaticojejunostomy
|
|
|
Active Comparator: Duct-to-duct anastomosis
Patients undergo right lobe living donor liver transplantation will receive duct-to-duct anastomosis
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biliary complications
Time Frame: 5 years
|
Compare all biliary-associated complications after operation including leakage and stricture
|
5 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operative time for liver transplantation
Time Frame: intraoperative
|
Duration of operative time
|
intraoperative
|
|
Gastrointestinal function after liver transplantation
Time Frame: 5 years
|
Return of gastrointestinal function
|
5 years
|
|
Hospital stay after liver transplantation
Time Frame: 5 years
|
Duration of hospital stay
|
5 years
|
|
Chances of re-intervention
Time Frame: 5 years
|
Re-intervention rate
|
5 years
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- UW 12-070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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