FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Echosens
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00708617

Purpose

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.

Condition
Alcoholic Liver Disease

MedlinePlus related topics: Liver Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Non Invasive Diagnostic Methods for Fibrosis in Alcoholic Liver Disease : FIBROSCAN Validation and Comparison of Fibrotest - FIBROSCAN Association With FIBROSCAN Alone

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with Alcoholic Liver Disease

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708617

Contacts

Contact: Sylvie Naveau, PhD

+33 (0)-1 4537 4372

sylvie.naveau@abc.aphp.fr

Locations

France
AP-HP Hôpital Antoine Beclere
Clamart, France, 92141
Hôpital Claude Huriez
Lille, France, 59037

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Echosens

Investigators

Study Chair:

Sylvie Naveau, PhD

Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

More Information

Responsible Party:	Departement Clinical Research Department ( Mathieu QUINTIN )
Study ID Numbers:	OST07008
Study First Received:	July 1, 2008
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00708617
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Liver fibrosis
Alcoholic liver disease
Non invasive diagnostic methods
Transient elastography
Fibrotest

Study placed in the following topic categories:

Alcohol-Induced Disorders
Liver Diseases, Alcoholic
Liver Diseases
Hepatic fibrosis
Digestive System Diseases

Fibrosis
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009