Clinical trial NCT01537965: Evaluation of Innovative Ultrasonic Techniques for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Viral Hepatitis B or C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fibrosis
Keywords: hepatitis
fibrosis
elastography
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2012-02-23
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 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.
timeFrame: two years
Secondary outcomes:
measure: 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.
timeFrame: two years
measure: 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).
timeFrame: two years
measure: 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)
timeFrame: two years
measure: 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
timeFrame: two years
measure: Kappa intra-observer coefficient of ultrasonic techniques
timeFrame: two years
measure: 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 ®).
timeFrame: two years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Vincent Leroy, Pr, PhD
role: PRINCIPAL_INVESTIGATOR
References: