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| Name | Class |
|---|---|
| Clinical Investigation Centre for Innovative Technology Network | NETWORK |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Leroy, Pr, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Grenoble | France |
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| 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). | 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) | 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) | 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) | 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 | 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. | two years |
| Kappa intra-observer coefficient of ultrasonic techniques | two years |
| 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 ®). | proportion of patients correctly classified by the new strategy for each grade of fibrosis. | two years |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006505 | Hepatitis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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