Evaluation of Innovative Ultrasonic Techniques for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Viral Hepatitis B or C

Not Applicable

Completed

• Conditions: Liver Fibrosis

• Registration Number: NCT01537965
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest® and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study) for the discrimination of F≤1 versus F≥2, the positive and negative predictive values , however, are far from be perfect in a given patient. With these technique, failures are also possible and the measures do not meet quality standards that increase the risk of misclassification. It would be particularly useful to have new generation techniques with a better diagnostic performance.

In this project, in response to the problems presented above, we propose to evaluate the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study Start: 2012-01
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-23
• Primary Completion: 2014-01
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-21
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• patient with an Ac-HCV positive and RNA HCV positive or AgHBs-positive,
• naive to treatment or not receiving treatment for viral eradication in six months,
• patient for whom a liver biopsy size less than 15 mm, regardless of the number of portal tracts present or fragments, is being considered or has been performed between two and one month before inclusion,
• Patient affiliated to social security or similar regime,
• patients who signed consent for participation in the study.

Exclusion Criteria

• patient with anti-HIV Ac positive (latter result not older than 12 months and in the absence of risk factors)
• chronic liver disease due to other causes than HCV (hemochromatosis, autoimmune hepatitis, autoimmune disease, metabolic liver disease, alcoholic liver disease, alcoholic liver disease, exposure to toxins ...)
• chronic alcohol consumption >30g/day in men and >20g/day in women
• history of severe systemic disease,
• HCV treatment with anti-viral or anti-fibrotic referred to within the last 6 months,
• immunosuppressive therapy: corticosteroids, Imurel, cyclosporine, tacrolimus, Cellcep,
• patient with an active implantable medical device,
• protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
In patients with chronic viral hepatitis B or C, evaluate the performance for the diagnosis of significant fibrosis (F≤1 versus F≥2) of elastography in mode supersonic compared with elastography (FibroScan®), the gold standard liver biopsy.	two years	Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibroscan® vs Aixplorer®).

Secondary Outcome Measures

Name	Time	Method
Evaluate the diagnostic performance of all approaches to all stages of fibrosis took 2 by 2 (F1 vs. F2, F2 vs. F3, F3 vs. F4)	two years	Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, elastography with Fibroscan®, elastography in mode supersonic, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Kappa intra-observer coefficient of ultrasonic techniques	two years
Compare the performance for the diagnosis of significant fibrosis of the liver contours regularity quantification and of the homogeneity of the hepatic parenchyma, and biological tests of fibrosis, the gold standard is liver biopsy.	two years	Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Evaluate the diagnostic performance of each technique (ultrasound innovative and organic) for severe fibrosis (F<3 vs F≥3) and cirrhosis (F<4 vs F≥4).	two years	Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibrotest®, Fibromètre®, elastography with Fibroscan®, elastography in mode supersonic, Acoustic Structure Quantification, Quantification of the Surface Regularity, elastography ARFI)
Evaluate the performance of the main diagnostic modalities chosen from previous results in the two sub-populations: patients with hepatitis B and those with hepatitis C	two years	Comparison of areas under the ROC curve obtained in the two sub-population (hepatisis B and C) for the main diagnostic modalities chosen from previous results.
Propose, based on previous results, a hierarchical strategy for using these innovative ultrasonic techniques used in combination with Fibroscan ® and the biological tests currently available (Fibrotest ®, FibroMetre ®).	two years	proportion of patients correctly classified by the new strategy for each grade of fibrosis.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Grenoble, France