NCT01537965

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2012-02-23
• Last updated: 2014-02-24

Locations

1 site across 1 country: France