Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Liver Transplantation
- Sponsor
- University Health Network, Toronto
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Biliary complications defined as leaks and strictures within the first year post LDLT;
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Biliary complications defined as leaks and strictures within the first year post LDLT;
Time Frame: 1 year
Secondary Outcomes
- Graft and patient survival(1 year post-transplant)
- Any infection or rejection episodes(1 year post- transplant)
- time to full oral nutrition(within 30 days of discharge)
- Length of hospital-stay and ICU-stay(within first 30 days after discharge)