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

Completed

• Conditions: Evidence of Liver Transplantation; Hepatocellular Carcinoma; Liver Cirrhosis
• Interventions: Other: search of factors predicting tumor recurrence

• Registration Number: NCT01198704
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2017-01
• Study Completion: 2020-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC patients	search of factors predicting tumor recurrence	Patients notified on the national waiting list for hepatic transplant

Primary Outcome Measures

Name	Time	Method
Predictive factors of HCC recurrence	at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Universitaire d'Hépato-gastroentérologie; 🇫🇷 Grenoble, France