Duct-to-duct vs Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

July 24, 2014 updated by: University Health Network, Toronto

Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.

Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient with end-stage liver disease
  • living donor liver transplantation using right hemi-liver as graft
  • duct anastomosis possible at time of surgery
  • donor and recipient aged 18 yrs or older
  • written informed consent obtained

Exclusion Criteria:

  • duct anastomosis not possible
  • acute fulminant liver failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
Procedure: surgical technique: duct-to-duct biliary reconstruction
surgical reconstruction
OTHER: 2
Procedure: surgical technique: roux-en-y biliary reconstruction
surgical reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biliary complications defined as leaks and strictures within the first year post LDLT;
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Graft and patient survival
Time Frame: 1 year post-transplant
1 year post-transplant
Length of hospital-stay and ICU-stay
Time Frame: within first 30 days after discharge
within first 30 days after discharge
Any infection or rejection episodes
Time Frame: 1 year post- transplant
1 year post- transplant
time to full oral nutrition
Time Frame: within 30 days of discharge
within 30 days of discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Markus Selzner, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (ESTIMATE)

March 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

June 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 07-0498-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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