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

This study has been completed.
Sponsor:
Collaborator:
Clinical Investigation Centre for Innovative Technology Network
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01537965
First received: December 15, 2011
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Liver Fibrosis
Device: Fibroscan® of Echosens, Aixplorer® of Supersonic Imagine, Aplio XG of Toshiba, QRS software developed by Pr I.Bricault, Acuson S2000 of Siemens

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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. [ Time Frame: two years ] [ Designated as safety issue: No ]
    Comparison 2-2 of areas under the ROC curve obtained for the different modalities (Fibroscan® vs Aixplorer®).


Secondary Outcome Measures:
  • 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. [ Time Frame: two years ] [ Designated as safety issue: No ]
    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). [ Time Frame: two years ] [ Designated as safety issue: No ]
    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 diagnostic performance of all approaches to all stages of fibrosis took 2 by 2 (F1 vs. F2, F2 vs. F3, F3 vs. F4) [ Time Frame: two years ] [ Designated as safety issue: No ]
    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 [ Time Frame: two years ] [ Designated as safety issue: No ]
    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.

  • Kappa intra-observer coefficient of ultrasonic techniques [ Time Frame: two years ] [ Designated as safety issue: No ]
  • 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 ®). [ Time Frame: two years ] [ Designated as safety issue: No ]
    proportion of patients correctly classified by the new strategy for each grade of fibrosis.


Enrollment: 96
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537965

Locations
France
University Hospital
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Clinical Investigation Centre for Innovative Technology Network
Investigators
Principal Investigator: Vincent Leroy, Pr, PhD University Hospital, Grenoble
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01537965     History of Changes
Other Study ID Numbers: DCIC 11 03
Study First Received: December 15, 2011
Last Updated: February 21, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
hepatitis
fibrosis
elastography

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014