Duct-to-duct vs Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00646685
• Other study ID #: 07-0498-B
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 25, 2008
• Last updated: July 24, 2014
• Start date: February 2008
• Est. completion date: July 2016

Study information

• Verified date: June 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.

Description:

The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.

Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patient with end-stage liver disease

• living donor liver transplantation using right hemi-liver as graft

• duct anastomosis possible at time of surgery

• donor and recipient aged 18 yrs or older

• written informed consent obtained

Exclusion Criteria:

• duct anastomosis not possible

• acute fulminant liver failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Procedure:
• surgical technique: duct-to-duct biliary reconstruction
surgical reconstruction
• surgical technique: roux-en-y biliary reconstruction
surgical reconstruction

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biliary complications defined as leaks and strictures within the first year post LDLT;		1 year	No
Secondary	Graft and patient survival		1 year post-transplant	Yes
Secondary	Length of hospital-stay and ICU-stay		within first 30 days after discharge	No
Secondary	Any infection or rejection episodes		1 year post- transplant	Yes
Secondary	time to full oral nutrition		within 30 days of discharge	No