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

NCT ID: NCT00708617

Last Updated: 2014-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 227 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2013-07-31

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.

Conditions

Alcoholic Liver Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Echosens

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Naveau, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

Locations

AP-HP Hôpital Antoine Beclere

Clamart, , France

Hôpital Claude Huriez

Lille, , France

AP-HP Hôpital Cochin

Paris, , France

Countries

France

Other Identifiers

OST07008

Identifier Type: -

Identifier Source: org_study_id