Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)

Study Overview
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Brief Summary
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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 reassess criteria for liver transplantation.

Detailed Description
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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.

Official Title
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Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma, Liver Cirrhosis, Evidence of Liver Transplantation

Intervention / Treatment
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* Other: search of factors predicting tumor recurrence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC patients<br>Patients notified on the national waiting list for hepatic transplant | Other: search of factors predicting tumor recurrence<br>* Morphological, chronological, anatomy-pathological and molecular search<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factors of HCC recurrence |  | at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factors of tumor-free recurrence |  | at 3 years | 
| Predictive factors of overall survival at 5 years |  | at 5 years | 
| Predictive factors of drop-out |  | during the waiting time | 
| Radio-pathological correlation |  | end of the study | 
| Correlation of HCC differentiation between liver biopsy and explant liver |  | at 32 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Cirrhosis, Transplantation