Text Size

Orthotopic Liver Transplantation Using a Living Donor

This study has been terminated.
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00152607
First received: September 8, 2005
Last updated: September 28, 2006
Last verified: September 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Disease
Liver Neoplasms
 Procedure: donor right hepatic lobectomy
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: April 2000
Estimated Study Completion Date: January 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-55
  2. No current or prior history of heart, lung or other medical problems.
  3. No history of liver disease.
  4. No history of malignancy, except limited basal cell carcinoma.
  5. ABO / HLA compatibility with the recipient.
  6. If female and premenopausal, a negative pregnancy test.
  7. Related to recipient either by blood or marriage and having a stable, long term, emotional relationship.
  8. The donor’s body size and volumetric determination of liver mass by abdominal CT scan will indicate whether or not a donor is a suitable candidate for liver donation if the donor meets the other inclusion criteria. Favorable donors for the individual organs will be those with donor graft to recipient body dry weight ratios (GRBWR) of >0.7% and those with a ratio of graft volume to recipient’s expected liver volume (GWRLW) of >35%.
  9. Satisfactory psychosocial evaluation. -

Exclusion Criteria:

Recipient Exclusion Criteria:

  1. Pregnant or nursing females.
  2. Patients with significant concomitant infections.
  3. Patients who require multiple organ transplants.
  4. Significant pulmonary disease. If pulmonary disease is clinically suspected, diagnostic studies will be performed to exclude the presence of pulmonary hypertension (PA systolic pressure >40 mm Hg) or arterial saturation (Po2<60 mmHg, breathing room air).

  5. Patients at a higher than average perioperative risk secondary to severe decompensated liver disease or previous surgery (i.e., re-transplantation) or infections.

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152607

Locations
United States, Illinois
The University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: J. Michael Millis, MD The University of Chicago Hospitals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00152607     History of Changes
Other Study ID Numbers: 10050
Study First Received: September 8, 2005
Last Updated: September 28, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Liver Transplantation
Living Donors
End Stage Liver Disease

Additional relevant MeSH terms:
Neoplasms
Liver Diseases
Liver Neoplasms
 Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 22, 2013