Status:
COMPLETED
FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Echosens
Conditions:
Alcoholic Liver Disease
Eligibility:
All Genders
18-75 years
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 us...
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 li...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00708617
Start Date
September 1 2008
End Date
July 1 2013
Last Update
January 23 2014
Active Locations (3)
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1
AP-HP Hôpital Antoine Beclere
Clamart, France, 92141
2
Hôpital Claude Huriez
Lille, France, 59037
3
AP-HP Hôpital Cochin
Paris, France, 75005