Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)
This trial is active, not recruiting.
|Conditions||hepatocellular carcinoma, liver cirrhosis, evidence of liver transplantation|
|Treatment||search of factors predicting tumor recurrence|
|Sponsor||Assistance Publique - Hôpitaux de Paris|
|Start date||January 2009|
|End date||March 2017|
|Trial size||372 participants|
|Trial identifier||NCT01198704, AOM07237|
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.
Patients notified on the national waiting list for hepatic transplant
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
time frame: end of the study
Correlation of HCC differentiation between liver biopsy and explant liver
time frame: at 32 month
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - Liver cirrhosis - Hepatocellular carcinoma diagnosed by AASLD criteria or liver biopsy - Listing for Liver transplantation for HCC fulfilling or not Milan criteria - No extra-hepatic spread - No vascular involvement Exclusion Criteria: - Salvage transplantation - Transplantation contra-indication - Evaluation for Liver transplantation older than 1 month - Incidental HCC
|Official title||Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma|
|Principal investigator||Thomas Decaens, MD, PhD|
|Description||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.|
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