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

NCT01537965 | Completed DMC

• 1 other identifier: DCIC 11 03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

hepatitis; fibrosis; elastography

Outcome Measures

Primary Outcomes (1)

• 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.

  Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibroscan® vs Aixplorer®).

  two years

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• Kappa intra-observer coefficient of ultrasonic techniques

  two years

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 affiliated to social security or similar regime,
• patients who signed consent for participation in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Sites (1)

University Hospital

Grenoble, France

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent Leroy, Pr, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: February 23, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

FR (1)