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NCT Number: NCT01198704

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Evidence of Liver Transplantation Fibrosis Liver Cirrhosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Universitaire d'Hépato-gastroentérologie

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

search of factors predicting tumor recurrence

Other

Morphological, chronological, anatomy-pathological and molecular search

Primary outcomes

  1. Predictive factors of HCC recurrence

    Time frame: at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)

Secondary outcomes

  1. Predictive factors of tumor-free recurrence

    Time frame: at 3 years

  2. Predictive factors of overall survival at 5 years

    Time frame: at 5 years

  3. Predictive factors of drop-out

    Time frame: during the waiting time

  4. Radio-pathological correlation

    Time frame: end of the study

  5. Correlation of HCC differentiation between liver biopsy and explant liver

    Time frame: at 32 month

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EFAPRE

Important dates

Study start
2009
Primary completion
2017
Study completion
2020
First posted
Sep 10, 2010
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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