FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease
Condition: Alcoholic Liver Disease
MeSH terms: Liver Diseases; Liver Diseases, Alcoholic; Fibrosis
Study type: Observational

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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Alcoholic Liver Disease
      
Keywords: Liver fibrosis; Alcoholic liver disease; Non invasive diagnostic methods; Transient elastography; Fibrotest