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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rafael Lopez Andujar, Hospital Universitario La Fe
ClinicalTrials.gov Identifier:
NCT01546064
First received: February 26, 2012
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Evidence of Liver Transplantation
Device: Choledocho-choledochostomy with T-tube
Device: Choledocho-choledochostomy without T-tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective and Randomized Trial on the Usefulness of T-Tube in the Bile Duct Anastomosis in Liver Transplantation Procedure.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario La Fe:

Primary Outcome Measures:
  • all morbidity related to bile duct [ Time Frame: The first year after liver transplantation procedure ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 200
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bile duct anastomosis with T-tube Device: Choledocho-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.
Active Comparator: Bile duct anastomosis without T-tube Device: Choledocho-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.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546064

Locations
Spain
La Fe University and Politechnic Hospital
Valencia, Spain, 46026
Sponsors and Collaborators
Hospital Universitario La Fe
Investigators
Principal Investigator: Rafael López-Andújar, Head of Unit La Fe University and Politechnic Hospital
  More Information

Publications:
Duailibi DF, Ribeiro Jr MAF. Biliary complications following deceased and living donor liver transplantation: a review. Transplant Proc 2010;42:517-20.
Ayoub WS, Esquivel CO, Martin P. Biliary complications following liver transplantation. Dig Dis Sci 2010;55:1540-1546.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rafael Lopez Andujar, Head of Unit, Hospital Universitario La Fe
ClinicalTrials.gov Identifier: NCT01546064     History of Changes
Other Study ID Numbers: ESTUDIOKEHR
Study First Received: February 26, 2012
Last Updated: March 1, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitario La Fe:
Bile duct anastomosis
Biliary complications

ClinicalTrials.gov processed this record on October 23, 2014