Clinical trial NCT01546064: Study to Establish Whether the Use of T-Tube in Bile Duct Anastomosis in Liver Transplantation Decreases Morbidity
Official title: Prospective and Randomized Trial on the Usefulness of T-Tube in the Bile Duct Anastomosis in Liver Transplantation Procedure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evidence of Liver Transplantation
Keywords: Bile duct anastomosis
Biliary complications
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: all morbidity related to bile duct
timeFrame: The first year after liver transplantation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: La Fe University and Politechnic Hospital
Study officials:
affiliation: La Fe University and Politechnic Hospital
name: Rafael López-Andújar, Head of Unit
role: PRINCIPAL_INVESTIGATOR
References:
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