Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

562 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-04-01

Brief Summary

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This is a French multicentric retrospective study on intention-to-treat comparing results of LT for HCC before and after the use of the AFP score. The investigators hypothesis is a better respect of the Biomedicine Agency (the French national transplantation agency) criteria since the general application of this score in March 2013. The aim of this study is to determine if the tumoral characteristics at the time of LT are improved and if it modified the patients'outcome.

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Detailed Description

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Liver transplantation is a widely accepted treatment for HCC as it would eliminate the tumour and cure the underlying liver disease. But the success of liver transplantation depends on the tumour load; patients with extensive disease have very poor outcomes, whereas most patients with small tumours can be curred. This had to be taken into account in the context of worldwide organ shortage.

That is why in 1996 Mazzaferro et al. have reported Milan criteria limiting access to liver transplantation for patients with a single tumor ≤ 5 cm or ≤ 3 tumors ≤ 3 cm without tumor invasion or metastasis.

However, in France, these criteria were not respected in about 30% of cases, because they were considered too restrictive and unadapted, with good overall results. This led to the possibility of new criteria definition. Because the value of alpha-foeto-protein was known as a good predictor of tumor aggressivity, a new score emerged in 2012, integrating blocking α-fetoprotein thresholds while allowing an increased number and size of tumors. After validation of this score, the Biomedicine Agency decided to use this α-fetoprotein score, to make the selection of patients allowed to be transplanted since March 2013.

In this multicentric retrospective comparative study The investigators first want to assess if this new score based on imaging is also respected at the explant analysis. Our secondary outcomes are to compare the amount of dropped out patients because of this score, the rate of tumoral relapse, the overall survival and the disease free survival.

The investigators aim at collecting the data of 562 patients registered for Liver Transplantation for Hepatocellular Carcinoma between 2011/03/01 and 2014/03/01 in 5 centres: Paul Brousse (Paris), Montpellier, Lille, Lyon and Grenoble.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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all participants included "Milan criteria " and "AFP score"

The first arm is made of liver recipients or dropped off list patients at the time of the Milan criteria (fixed until 2013/06/01 for transplanted patients because mandatory three months reevaluation of patients obliged the various teams to respect the criteria at this time, but until 2013/03/01 for dropped off patients because we did not want to count dropped of because of the AFP score in this arm).

The second arm is made of liver recipients or dropped off list patients at the time of the AFP score (fixed after 2013/06/01)for transplanted patients and after 2013/03/01 for dropped off patients)

Data collecting

Intervention Type OTHER

Interventions

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Data collecting

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients registered for liver transplantation because of Hepatocellular carcinoma between 2011/03/01 and 2014/03/01 in 5 french hospital : Paul Brousse (Paris), Montpellier, Lille Lyon and Grenoble

Exclusion Criteria

* Patients with a MELD score superior to 20 (because this rate give them access to liver transplantation sooner than the other patients).
* Patients of Domino's grafts
* patients with non hepatocellular tumors on the explanted liver

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No