- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069416
Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria
Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria in High Prevalence Young HCC Patients Country.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction:
HEPATOCELLULAR CARCINOMA (HCC) is the second leading cause of cancer mortality worldwide. Living donor liver transplantation (LDLT) for HCC patients has emerged as a rewarding therapy for a cure and a successful alternative where a Deceased donor liver transplantation (DDLT) program is lacking. Therefore, trials for careful expansion to Milan criteria have been adopted.
Aim of the study:
To evaluate the impact of expanding criteria beyond Milan on tumor recurrence and patient survival that will help identify the best selection criteria for HCC transplanted patients
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients were divided according to the pre-transplant radiological findings of HCC nodules number and sizes into 3 groups:
Group I: comprised 175 patients who fall within the Milan criteria. Group II: included 36 patients who fall within up-to-7 criteria (the sum of the number of the tumors and diameter of the largest tumor not exceeding 7cm) Group III: included 30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC).
Description
Inclusion Criteria:
- All patient transplanted for HCC eligible for transplant (no vascular invasion-no extra hepatic metastasis)
- age>18y
Exclusion Criteria:
- other etiology for liver transplant rather than HCC
- patient not fit for surgery
- age >70y
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group I
175 patients who fall within the Milan criteria.
|
liver graft from a living donor
|
Group II
36 patients who fall within up-to-7 criteria
|
liver graft from a living donor
|
Group III
30 patients beyond up-to-7 criteria and will be termed beyond all criteria (BAC).
|
liver graft from a living donor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HCC recurrence
Time Frame: 3 years
|
Recurrence of Hepatocellular carcinoma either intra-hepatic, extra-hepatic or both
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 68954200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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