FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease

Completed

• Conditions: Alcoholic Liver Disease

• Registration Number: NCT00708617
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-02
• Study Start: 2008-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	up to one week

Secondary Outcome Measures

Name	Time	Method
Diagnostic values of the diagnostic tests will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves.	up to one week

Trial Locations

Locations (3)

Hôpital Claude Huriez; 🇫🇷 Lille, France

AP-HP Hôpital Antoine Beclere; 🇫🇷 Clamart, France

AP-HP Hôpital Cochin; 🇫🇷 Paris, France