Document Detail

Diagnostic accuracy of FibroScan and comparison to liver fibrosis biomarkers in chronic viral hepatitis: a multicenter prospective study (the FIBROSTIC study).
MedLine Citation:
PMID:  20850886     Owner:  NLM     Status:  MEDLINE    
BACKGROUND & AIMS: The diagnostic accuracy of non-invasive liver fibrosis tests that may replace liver biopsy in patients with chronic hepatitis remains controversial. We assessed and compared the accuracy of FibroScan® and that of the main biomarkers used for predicting cirrhosis and significant fibrosis (METAVIR ≥ F2) in patients with chronic viral hepatitis.
METHODS: A multicenter prospective cross-sectional diagnostic accuracy study was conducted in the Hepatology departments of 23 French university hospitals. Index tests and reference standard (METAVIR fibrosis score on liver biopsy) were measured on the same day and interpreted blindly. Consecutive patients with chronic viral hepatitis (hepatitis B or C virus, including possible Human Immunodeficiency Virus co-infection) requiring liver biopsy were recruited in the study.
RESULTS: The analysis was first conducted on the total population (1839 patients), and after excluding 532 protocol deviations, on 1307 patients (non-compliant FibroScan® examinations). The overall accuracy of FibroScan® was high (AUROC 0.89 and 0.90, respectively) and significantly higher than that of biomarkers in predicting cirrhosis (AUROC 0.77-0.86). All non-invasive methods had a moderate accuracy in predicting significant fibrosis (AUROC 0.72-0.78). Based on multilevel likelihood ratios, non-invasive tests provided a relevant gain in the likelihood of diagnosis in 0-60% of patients (cirrhosis) and 9-30% of patients (significant fibrosis).
CONCLUSIONS: The diagnostic accuracy of non-invasive tests was high for cirrhosis, but poor for significant fibrosis. A clinically relevant gain in the likelihood of diagnosis was achieved in a low proportion of patients. Although the diagnosis of cirrhosis may rely on non-invasive tests, liver biopsy is warranted to diagnose intermediate stages of fibrosis.
Francoise Degos; Paul Perez; Bruno Roche; Amel Mahmoudi; Julien Asselineau; Hélène Voitot; Pierre Bedossa;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2010-08-14
Journal Detail:
Title:  Journal of hepatology     Volume:  53     ISSN:  1600-0641     ISO Abbreviation:  J. Hepatol.     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-11-02     Completed Date:  2011-02-24     Revised Date:  2012-08-24    
Medline Journal Info:
Nlm Unique ID:  8503886     Medline TA:  J Hepatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  1013-21     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
APHP, Hôpital Beaujon, Hepatology Dept., INSERM U 773, Clichy, France.
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MeSH Terms
Biological Markers / blood
Biopsy, Needle
Cross-Sectional Studies
Elasticity Imaging Techniques / methods*
Hepatitis B, Chronic / blood,  diagnosis
Hepatitis C, Chronic / blood,  diagnosis
Hepatitis, Viral, Human / blood,  diagnosis*
Liver Cirrhosis / blood,  diagnosis*
Middle Aged
Predictive Value of Tests
Prospective Studies
Reg. No./Substance:
0/Biological Markers
Comment In:
J Hepatol. 2011 Jul;55(1):233; author reply 234-5   [PMID:  21295091 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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