Evidence of Liver Transplantation, Hepatocellular Carcinoma, Liver Cirrhosis
Conditions
Keywords
Hepatocellular carcinoma, Cirrhosis, Transplantation
Brief summary
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
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.
Interventions
OTHERsearch of factors predicting tumor recurrence
Morphological, chronological, anatomy-pathological and molecular search
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predictive factors of HCC recurrence | at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013) |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed