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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT00646685

Collaborator

(none)

Enrollment

Location

Arms

101

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Liver Transplantation	Procedure: surgical technique: duct-to-duct biliary reconstruction Procedure: surgical technique: roux-en-y biliary reconstruction	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Biliary complications defined as leaks and strictures within the first year post LDLT; [1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00646685

Other Study ID Numbers:

07-0498-B

First Posted:

Mar 28, 2008

Last Update Posted:

Jul 25, 2014

Last Verified:

Jun 1, 2012

Study Results

No Results Posted as of Jul 25, 2014