Liver Neoplasms Clinical Trial
Official title:
Orthotopic Liver Transplantation Using a Living Donor Into An Adult Recipient
Verified date | September 2013 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | September 2006 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The University of Chicago Hospitals | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | post transplant | Yes | |
Primary | 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. | post transplant | No |
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