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Evaluation and Medico-Economic Study of FIBROSCAN in Patients With Viral Hepatitis (FIBROSTIC)

This study has been terminated.
(enough patients have been enrolled for the statistic analysis)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00318682
First received: April 25, 2006
Last updated: February 11, 2009
Last verified: September 2006
History of Changes
  Purpose

A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the METAVIR score. This transversal study aims to compare the evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550 consecutive patients taken in charge for a liver biopsy. The results of the study will compare the respective performances of these techniques in the prediction of the METAVIR score, and help in the recommendation of the care of patients with viral hepatitis B and C; these methods will undergo a medico-economic study.


Condition Intervention
Hepatitis, Viral, Human
 Device: FIBROSCAN

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation and Medico Economic Study of FIBROSCAN in Patients With Viral Hepatitis

Resource links provided by NLM:

U.S. FDA Resources

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

Biospecimen Retention:   Samples Without DNA

biological samples to evaluate the hepato-fibrosis


Enrollment: 2000
Study Start Date: May 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: FIBROSCAN
    diagnostic examination of the hepato fibrosis
Detailed Description:

The gold standard for the evaluation of fibrosis is considered as the METAVIR score by the clinicians. The results of this score are currently used for clinical decisions and description of the evolution of the disease. FIBROSCAN would be interesting in avoiding liver biopsies, if it was able to predict accurately the METAVIR score obtained if a liver biopsy was performed. The data available on diagnostic performances of FIBROSCAN are incomplete, the number of patients studied and the methods selection (blindness of the results of other techniques) are not precise in some of them. The main objective of this study is therefore to evaluate the performance of FIBROSCAN in the prediction of METAVIR score > 2 (vs F0 or F1). An ancillary study will try to evaluate the diagnostic performance of FIBROSCAN in the global prediction of METAVIR score. A statistical method will be tested using the reference method as an ordinal polytropic variable. Half of the sample (1250 patients) will be used to determine the best THERSHOLD of FIBROSCAN in each of the clinical subgroups of patients, in order to obtain a high sensibility. The second half will be used as the validation sample, and the threshold will be used to estimate the sensibility, specificity and other diagnostic parameters of the FIBROSCAN. The secondary objectives are:

  1. to evaluate the performance of FIBROSCAN in the prediction of METAVIR score in adjacent classes of fibrosis (F0-F1, F1-F2, F2-F3, F3-F4), and
  2. to study the association between elastometry and fibrosis surface obtained by morphometry (considered as the best evaluation of global liver fibrosis).

This technique will be applied to a restricted number of biopsies (consecutive biopsies > 2cm).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patient with hepatitis B or C

Criteria

Inclusion Criteria:

  • Chronic hepatitis B or C
  • With liver biopsy indication
  • Patient information

Exclusion Criteria:

  • Drug hepatitis
  • Metabolic hepatology
  • Steatosis or non-alcoholic steatohepatitis
  • Autoimmune hepatopathy
  • Non-contraindication to liver biopsy
  • Non-contraindication to FIBROSCAN examination
  • Ascites
  • Obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318682

Locations
France
Hopital Beaujon
Clichy, France, 92110
Hopital Saint-Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Francoise Degos, PhD Hopital Beaujon
  More Information

No publications provided

Responsible Party: Mathieu QUINTIN, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00318682     History of Changes
Other Study ID Numbers: IC0504
Study First Received: April 25, 2006
Last Updated: February 11, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
biopsy
FIBROSCAN

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on May 23, 2013