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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00708617
First Posted: July 2, 2008
Last Update Posted: January 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Echosens
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
July 1, 2008
July 2, 2008
January 23, 2014
September 2008
July 2013   (Final data collection date for primary outcome measure)
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 [ Time Frame: up to one week ]
Same as current
Complete list of historical versions of study NCT00708617 on ClinicalTrials.gov Archive Site
Diagnostic values of the diagnostic tests will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. [ Time Frame: up to one week ]
Same as current
Not Provided
Not Provided
 
FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease
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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with Alcoholic Liver Disease
Alcoholic Liver Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00708617
OST07008
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Echosens
Study Chair: Sylvie Naveau, PhD Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Assistance Publique - Hôpitaux de Paris
January 2014