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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Evidence of Liver Transplantation; Liver Cirrhosis; Hepatocellular Carcinoma

Treatments: Other: search of factors predicting tumor recurrence

Study type: Observational

Funder types: Other

Identifiers

NCT01198704

AOM07237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

372 participants in 1 patient group

HCC patients

Description:

Patients notified on the national waiting list for hepatic transplant

Treatment:

Other: search of factors predicting tumor recurrence