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| Name | Class |
|---|---|
| Johann Wolfgang Goethe University Hospital | OTHER |
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Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver.
This study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.
The measurements of liver stiffness made by the Aixplorer® will be compared to (where available) :
The influence of other (confounding) factors on the reliability of SWE measurements will be analyzed.
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation coefficients between factors and liver stiffness | Factors include patient's clinical and biological parameters | Within one year of the study start date |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rates depending on factors | Factors include patient's clinical and biological parameters | Within one year of the study start date |
| Diagnostic performance of multivariate models to assess liver fibrosis levels |
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Inclusion Criteria:
Patients meeting a single condition below:
And meeting all of the conditions below:
Exclusion Criteria:
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Population will consist of patients who have confirmed or suspected liver fibrosis and will be assessed with ultrasound, +/- blood analysis, +/- other non-invasive imaging, and/or measurements, and biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Mireen Freidrich-Rust | Johan Goethe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Antwerp | Edegem | Belgium | ||||
| 3rd Hospital of Sun Yat-sen University |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Determined by histological examination of liver biopsy. The resulting tests will be compared on the basis of their AUROC and test of statistical differences.
Fibrosis levels involved are:
| Within one year of the study start date |
| Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis | This will be determined by histological examination of liver biopsy | Within one year of the study start date |
| Guangzhou, Guangdong |
| China |
| Odense University Hospital | Odense | Denmark |
| University Hospital of Bordeaux | Bordeaux | France |
| Beaujon Hospital | Clichy | France |
| Hopital Edouard Herriot | Lyon | France |
| Cochin Hospital | Paris | France |
| University of Bonn | Bonn | Germany |
| Johan Goethe Universitat | Frankfurt | Germany |
| University of Athens Medical School | Athens | Greece |
| Chinese University of Hong Kong - Prince of Wales Hospital | Hong Kong | Hong Kong |
| University of Pavia | Pavia | Italy |
| University of Timosoara | Timișoara | Romania |