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

NCT ID: NCT01537965

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Liver Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Fibroscan® of Echosens, Aixplorer® of Supersonic Imagine, Aplio XG of Toshiba, QRS software developed by Pr I.Bricault, Acuson S2000 of Siemens

Five ultrasounds exams are realised:

• elastography with Fibroscan®
• ultrasound elastography in supersonic mode with Aixplorer®
• ultrasound analysis of the surface liver with QRS software,
• quantification of acoustic structure with Aplio XG,
• elastography ARFI with Acuson S2000.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Leroy, Pr, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital

Grenoble, , France

Countries

France

Other Identifiers

DCIC 11 03

Identifier Type: -

Identifier Source: org_study_id