Clinical trial NCT00708617: FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease
Official title: Non Invasive Diagnostic Methods for Fibrosis in Alcoholic Liver Disease : FIBROSCAN Validation and Comparison of Fibrotest - FIBROSCAN Association With FIBROSCAN Alone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Liver Disease
Keywords: Liver fibrosis
Alcoholic liver disease
Non invasive diagnostic methods
Transient elastography
Fibrotest
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Echosens
First posted: 2008-07-02
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alcoholic Liver Disease

Brief summary: Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C. However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry) are already used in current practice. The aim of this study is to validate the diagnostic value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this diagnostic strategy.

Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve of the scores will be compared using Z test.

Detailed description: Alcoholic liver disease (ALD) is highly prevalent and liver fibrosis and cirrhosis are asymptomatic for a long time. Liver biopsy in patients with ALD is designed to determine the prognostic of the liver lesions and to manage cirrhosis. Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C. However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry) are already used in current practice. The aim of this study is to validate the diagnostic value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this diagnostic strategy.

200 consecutive excessive drinkers with aminotransferase anomalies or suspicion of cirrhosis will be included in the study over a period of 2 years. All patient will have intercostal liver biopsy, assessment of the non-invasive biological scores of liver fibrosis and transient elastography.

Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve of the scores will be compared using Z test. Multivariate analyses will be used to identify the scores with an independent diagnostic value and therefore that could be associated.

This study will allow to select the non-invasive marker(s) with the best diagnostic values in order to identify early fibrosis in patients with ALD.

Eligibility criteria: Inclusion Criteria:

* consecutive excessive drinkers
* both gender
* aged 18 to 75 years,
* hospitalized to manage alcoholic liver disease
* Ag HBs -, HIV -, HCV -, without any other liver disease than alcohol abuse,
* with alcohol consumption greater than 80 g per day for at least 5 years
* with aminotransferase levels anomalies (ASAT ≥ 1.5 N and ALAT \> N) or suspicion of cirrhosis

Exclusion Criteria:

* any other liver disease than alcohol abuse,
* ascitis,
* contraindication to intercostal liver biopsy
* IMC\>30
* liver carcinoma
* other carcinoma
* serious associate disease
* platelets \< 60 GIGAS/L or Quick time \< 50% or TCA \> 1.5 witness time
* treatment with Plavix® or platelet antiaggregant or anticoagulant
* intercostal liver biopsy refusal

Primary outcomes:
measure: Patients will be classified according to existence of significant fibrosis (METAVIR score>=2)and cirrhosis (METAVIR score=4) Areas under ROC curve of the diagnostic tests
timeFrame: up to one week
Secondary outcomes:
measure: Diagnostic values of the diagnostic tests will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves.
timeFrame: up to one week
Other outcomes:
Locations:
city: Clamart
country: France
facility: AP-HP Hôpital Antoine Beclere
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Paris
country: France
facility: AP-HP Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
name: Sylvie Naveau, PhD
role: STUDY_CHAIR
References: