Study to Establish Whether the Use of T-Tube in Bile Duct Anastomosis in Liver Transplantation Decreases Morbidity

March 1, 2012 updated by: Rafael Lopez Andujar, Hospital Universitario La Fe

Prospective and Randomized Trial on the Usefulness of T-Tube in the Bile Duct Anastomosis in Liver Transplantation Procedure.

The purpose of this study was to compare the incidence and severity of biliary complications due to liver transplantation after choledochocholedochostomy with or without a T-tube. A per-protocol analysis was designed for recipients of orthotopic liver transplantation in a single center, who were randomly assigned to choledochocholedochostomy with or without a T-tube. It is a prospective and randomized study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

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

  • Spain
      • Valencia, Spain, 46026
        • La Fe University and Politechnic 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 67 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recipients of a deceased full-size liver graft
  • Aged > 18 years

Exclusion Criteria:

  • Age < 18 years
  • Retransplantation
  • Primary sclerosing cholangitis
  • Fulminant hepatic failure
  • Technical need for a hepaticojejunostomy
  • Splitted graft
  • Reduced-size graft
  • More than one organ transplantation
  • Living donation
  • Finding of a large difference (twice the size) in common bile duct diameters between the graft and the recipient

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bile duct anastomosis with T-tube
Device: Choledocho-choledochostomy with T-tube
In the anastomosis between the common bile duct of the graft and the common bile duct of the recipient, a tutorial T-tube is inserted in the bile duct lumen and will be removed from the patient on third month postoperatively.
ACTIVE_COMPARATOR: Bile duct anastomosis without T-tube
Device: Choledocho-choledochostomy without T-tube
The termino-terminal anastomosis between common bile duct of the graft and common bile duct of the recipient is performed without any T-tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all morbidity related to bile duct
Time Frame: The first year after liver transplantation procedure
All the complications related to bile duct that appear after transplantation will be recorded in both groups. All patients will be followed up for the first 12 months after transplantation.
The first year after liver transplantation procedure

Collaborators and Investigators

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

Sponsor

Hospital Universitario La Fe

Investigators

  • Principal Investigator: Rafael López-Andújar, Head of Unit, La Fe University and Politechnic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2008

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

February 26, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (ESTIMATE)

March 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ESTUDIOKEHR

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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