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

Phase 4

• Conditions: Liver Transplantation

• Registration Number: NCT00646685
• Lead Sponsor: University Health Network, Toronto

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.

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Status Verified: 2012-06
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-25
• Primary Completion: 2015-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• duct anastomosis not possible
• acute fulminant liver failure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biliary complications defined as leaks and strictures within the first year post LDLT;	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada