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

April 25, 2006
February 11, 2009
May 2006
August 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00318682 on ClinicalTrials.gov Archive Site
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Evaluation and Medico-Economic Study of FIBROSCAN in Patients With Viral Hepatitis
Evaluation and Medico Economic Study of FIBROSCAN in Patients With Viral Hepatitis

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

biological samples to evaluate the hepato-fibrosis

Non-Probability Sample

patient with hepatitis B or C

Hepatitis, Viral, Human
Device: FIBROSCAN
diagnostic examination of the hepato fibrosis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2000
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00318682
IC0504
No
Mathieu QUINTIN, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Francoise Degos, PhD Hopital Beaujon
Assistance Publique - Hôpitaux de Paris
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP