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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00646685
First received: March 25, 2008
Last updated: July 24, 2014
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
Procedure: surgical technique: duct-to-duct biliary reconstruction
Procedure: surgical technique: roux-en-y biliary reconstruction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Biliary complications defined as leaks and strictures within the first year post LDLT; [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft and patient survival [ Time Frame: 1 year post-transplant ] [ Designated as safety issue: Yes ]
  • Length of hospital-stay and ICU-stay [ Time Frame: within first 30 days after discharge ] [ Designated as safety issue: No ]
  • Any infection or rejection episodes [ Time Frame: 1 year post- transplant ] [ Designated as safety issue: Yes ]
  • time to full oral nutrition [ Time Frame: within 30 days of discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: surgical technique: duct-to-duct biliary reconstruction
surgical reconstruction
2 Procedure: surgical technique: roux-en-y biliary reconstruction
surgical reconstruction

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646685

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Markus Selzner, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00646685     History of Changes
Other Study ID Numbers: 07-0498-B
Study First Received: March 25, 2008
Last Updated: July 24, 2014
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on August 19, 2014