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

Hospital Universitario La Fe200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Evidence of Liver Transplantation

Interventions

Choledocho-choledochostomy with T-tubeDEVICE

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.

Choledocho-choledochostomy without T-tubeDEVICE

The termino-terminal anastomosis between common bile duct of the graft and common bile duct of the recipient is performed without any T-tube.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 67 Years

Medical Language ↔ Plain English

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

Locations (1)

La Fe University and Politechnic Hospital

Valencia, Valencia, Spain

Outcomes

Primary Outcomes

all morbidity related to bile duct

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.

Time frame: The first year after liver transplantation procedure

Data from ClinicalTrials.gov

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