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Randomized Trial of Hepaticojejunostomy Versus Duct-to-duct Anastomosis in Right Lobe Living Donor Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04139473
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Kenneth Siu-Ho Chok, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Liver Failure Procedure: Hepaticojejunostomy / Duct-to-duct anastomosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Trial of Hepaticojejunostomy Versus Duct-to-duct Anastomosis in Right Lobe Living Donor Liver Transplantation
Actual Study Start Date : May 15, 2012
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hepaticojejunostomy
Patients undergo right lobe living donor liver transplantation will receive hepaticojejunostomy
Procedure: Hepaticojejunostomy / Duct-to-duct anastomosis
Active Comparator: Duct-to-duct anastomosis
Patients undergo right lobe living donor liver transplantation will receive duct-to-duct anastomosis
Procedure: Hepaticojejunostomy / Duct-to-duct anastomosis



Primary Outcome Measures :
  1. Biliary complications [ Time Frame: 5 years ]
    Compare all biliary-associated complications after operation including leakage and stricture


Secondary Outcome Measures :
  1. Operative time for liver transplantation [ Time Frame: intraoperative ]
    Duration of operative time

  2. Gastrointestinal function after liver transplantation [ Time Frame: 5 years ]
    Return of gastrointestinal function

  3. Hospital stay after liver transplantation [ Time Frame: 5 years ]
    Duration of hospital stay

  4. Chances of re-intervention [ Time Frame: 5 years ]
    Re-intervention rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139473


Contacts
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Contact: Kenneth Chok, MBBS 22553025 ext 085228592111 chok6275@hku.hk

Locations
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Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Kenneth Chok, MBBS    085222553025 ext 085222553025    chok6275@hku.hk   
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong

Publications:

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Responsible Party: Dr. Kenneth Siu-Ho Chok, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04139473    
Other Study ID Numbers: UW 12-070
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases