Alcoholic Liver Disease Clinical Trial
Official title:
Non Invasive Diagnostic Methods for Fibrosis in Alcoholic Liver Disease : FIBROSCAN Validation and Comparison of Fibrotest - FIBROSCAN Association With FIBROSCAN Alone
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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