Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC) (EFAPRE)
Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.
The purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassessed criteria for liver transplantation.
|Hepatocellular Carcinoma Liver Cirrhosis Evidence of Liver Transplantation||Other: search of factors predicting tumor recurrence|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma|
- Predictive factors of HCC recurrence [ Time Frame: at 1 year after Liver transplantation for HCC ]
- Predictive factors of tumor-free recurrence [ Time Frame: at 3 years ]
- Predictive factors of overall survival at 5 years [ Time Frame: at 5 years ]
- Predictive factors of drop-out [ Time Frame: during the waiting time ]
- Radio-pathological correlation [ Time Frame: end of the study ]
- Correlation of HCC differentiation between liver biopsy and explant liver [ Time Frame: at 32 month ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Patients notified on the national waiting list for hepatic transplant
Other: search of factors predicting tumor recurrence
Morphological, chronological, anatomy-pathological and molecular search
In this study, the investigators studied the predictive value of imaging techniques such as CT, MRI, PET scan, of serological markers and molecular markers assessed before liver transplantation at listing.
The investigators also evaluated the predictive value of tumor growing during the waiting time (imaging and serological).
Finally, the investigators compared pre-LT data and explanted liver analysis to evaluate accuracy of liver biopsy and of imaging.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198704
|Henri Mondor Hospital|
|Creteil, France, 94010|
|Principal Investigator:||Thomas Decaens, MD, PhD||Assistance Publique - Hôpitaux de Paris|