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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01546064

Enrollment

200

Registered

2012-03-07

Start date

2008-05-31

Completion date

2011-07-31

Last updated

2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evidence of Liver Transplantation

Keywords

Bile duct anastomosis, Biliary complications

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.

Interventions

DEVICECholedocho-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.

DEVICECholedocho-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 67 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026