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

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ClinicalTrials.gov Identifier: NCT01546064
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):
Rafael Lopez Andujar, Hospital Universitario La Fe

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.

Condition or disease Intervention/treatment
Evidence of Liver Transplantation Device: Choledocho-choledochostomy with T-tube Device: Choledocho-choledochostomy without T-tube

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2008
Primary Completion Date : July 2010
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

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
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Rafael Lopez Andujar, Hospital Universitario La Fe:
Bile duct anastomosis
Biliary complications