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

Not Applicable

Completed

• Conditions: Evidence of Liver Transplantation
• Interventions: Device: Choledocho-choledochostomy with T-tube; Device: Choledocho-choledochostomy without T-tube

• Registration Number: NCT01546064
• Lead Sponsor: Hospital Universitario La Fe

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2010-07
• Study Completion: 2011-07
• Study First Submitted: 2012-02-26
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-01
• Last Update Submitted: 2012-03-01
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bile duct anastomosis with T-tube	Choledocho-choledochostomy with T-tube	-
Bile duct anastomosis without T-tube	Choledocho-choledochostomy without T-tube	-

Primary Outcome Measures

Name	Time	Method
all morbidity related to bile duct	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.

Trial Locations

Locations (1)

La Fe University and Politechnic Hospital; 🇪🇸 Valencia, Spain