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

NCT ID: NCT00646685

Last Updated: 2014-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

surgical technique: duct-to-duct biliary reconstruction

Intervention Type PROCEDURE

surgical reconstruction

2

Group Type OTHER

surgical technique: roux-en-y biliary reconstruction

Intervention Type PROCEDURE

surgical reconstruction

Interventions

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surgical technique: duct-to-duct biliary reconstruction

surgical reconstruction

Intervention Type PROCEDURE

surgical technique: roux-en-y biliary reconstruction

surgical reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markus Selzner, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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07-0498-B

Identifier Type: -

Identifier Source: org_study_id

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