Orthotopic Liver Transplantation Using a Living Donor
The purpose of this study is to:
determine the safety of donor right hepatic lobectomy as a procedure to provide a liver graft for living donor liver transplantation.
study the regeneration of liver tissue by volumetric testing for both donor and recipient.
assess if graft and patient survival with living donor transplantation is comparable to that of cadaveric donor transplantation.
Procedure: donor right hepatic lobectomy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Orthotopic Liver Transplantation Using a Living Donor Into An Adult Recipient|
- The primary outcome for donors in this study will be the determination of whether right hepatic lobectomy is a safe procedure for the donor as measured by survival, the incidence of surgical complications, liver function and regeneration studies.
- The primary outcome for recipients will be the assessment of patient and graft survival. Comparison to results of contemporaneous, non-randomized cadaver donor transplants will be made.
- Graft survival will be measured from the date of transplant to the date of graft failure.
- Patient survival will be measured from the date of transplant to the date of patient death.
- Recipient graft function will be measured by means of liver function tests (bilirubin, prothrombin time, SGPT, SGOT, alkaline phosphatase, GGTP) at routine intervals in posttransplant follow-up.
- Donor hepatic function will also be documented by these tests, during the immediate posttransplant period and at 1, 3 and 6 month’s follow-up.
- The regeneration of liver tissue in both donors and recipients will be evaluated by liver function tests and computerized tomography.
- Incidence, type and severity of adverse experiences in the recipient will be evaluated and compared to that of cadaver donor transplant recipients.
- The time, incidence and severity of rejection episodes in recipients of living donor transplants will be evaluated and compared to that of a cohort of cadaver donor transplant recipients.
|Study Start Date:||April 2000|
|Estimated Study Completion Date:||January 2009|
|United States, Illinois|
|The University of Chicago Hospitals|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||J. Michael Millis, MD||The University of Chicago Hospitals|