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

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.

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Key information

Conditions

Evidence of Liver Transplantation

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Fe University and Politechnic Hospital

Valencia, 46026, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choledocho-choledochostomy with T-tube

Device

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-tube

Device

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Mar 7, 2012
Registry last updated: Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed