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

This study has been completed.
Sponsor:
Collaborator:
Echosens
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00708617
First received: July 1, 2008
Last updated: January 22, 2014
Last verified: January 2014
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 227
Study Start Date: September 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
AP-HP Hôpital Antoine Beclere
Clamart, France, 92141
Hôpital Claude Huriez
Lille, France, 59037
AP-HP Hôpital Cochin
Paris, France, 75005
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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00708617     History of Changes
Other Study ID Numbers: OST07008
Study First Received: July 1, 2008
Last Updated: January 22, 2014
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

Additional relevant MeSH terms:
Fibrosis
Liver Diseases
Liver Diseases, Alcoholic
Pathologic Processes
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 27, 2014