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

NCT01546064 | Completed

• 1 other identifier: ESTUDIOKEHR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Evidence of Liver Transplantation

Keywords

Bile duct anastomosis; Biliary complications

Outcome Measures

Primary Outcomes (1)

• all morbidity related to bile duct

  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.

  The first year after liver transplantation procedure

Study Arms (2)

Bile duct anastomosis with T-tube

ACTIVE COMPARATOR

Device: Choledocho-choledochostomy with T-tube

Bile duct anastomosis without T-tube

ACTIVE COMPARATOR

Device: Choledocho-choledochostomy without T-tube

Interventions

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.

Bile duct anastomosis with T-tube

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.

Bile duct anastomosis without T-tube

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipients of a deceased full-size liver graft
• Aged \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

La Fe University and Politechnic Hospital

Valencia, Valencia, 46026, Spain

Location

Related Publications (32)

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  PMID: 14263542 BACKGROUND

• Lopez-Andujar R, Oron EM, Carregnato AF, Suarez FV, Herraiz AM, Rodriguez FS, Carbo JJ, Ibars EP, Sos JE, Suarez AR, Castillo MP, Pallardo JM, De Juan Burgueno M. T-tube or no T-tube in cadaveric orthotopic liver transplantation: the eternal dilemma: results of a prospective and randomized clinical trial. Ann Surg. 2013 Jul;258(1):21-9. doi: 10.1097/SLA.0b013e318286e0a0.

  PMID: 23426348 DERIVED

Study Officials

• Rafael López-Andújar, Head of Unit

  La Fe University and Politechnic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit

Study Record Dates

• First Submitted: February 26, 2012
• First Posted: March 7, 2012
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

ES (1)