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

La Fe University and Polytechnic Hospital

Status: Completed

Conditions: Evidence of Liver Transplantation

Treatments: Device: Choledocho-choledochostomy with T-tube; Device: Choledocho-choledochostomy without T-tube

Study type: Interventional

Funder types: Other

Identifiers

NCT01546064

ESTUDIOKEHR

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Bile duct anastomosis with T-tube

Active Comparator group

Treatment:

Device: Choledocho-choledochostomy with T-tube

Bile duct anastomosis without T-tube

Active Comparator group

Treatment:

Device: Choledocho-choledochostomy without T-tube