Alcoholic Liver Disease Clinical Trial
— FIBROMAFOfficial title:
Non Invasive Diagnostic Methods for Fibrosis in Alcoholic Liver Disease : FIBROSCAN Validation and Comparison of Fibrotest - FIBROSCAN Association With FIBROSCAN Alone
Verified date | January 2014 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 227 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | AP-HP Hôpital Antoine Beclere | Clamart | |
France | Hôpital Claude Huriez | Lille | |
France | AP-HP Hôpital Cochin | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Echosens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Diagnostic values of the diagnostic tests will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. | up to one week | No |
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