Liver Fibrosis
Conditions
Keywords
liver, fibrosis, ShearWave Elastography, ultrasound
Brief summary
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.
Detailed description
The measurements of liver stiffness made by the Aixplorer® will be compared to (where available) : * blood markers * biopsy results * other stiffness measurement exams (FibroScan, ARFI, ElastPQ...) The influence of other (confounding) factors on the reliability of SWE measurements will be analyzed.
Interventions
None listed
Sponsors
Johann Wolfgang Goethe University Hospital
SuperSonic Imagine
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients meeting a single condition below: * Chronic hepatitis B, defined by serology HBsAg positive and the presence of DNA / RNA in the serum, or * Chronic hepatitis C, defined by serology anti-HCV positive and the presence of DNA / RNA in the serum, or * non-alcoholic fatty-liver disease * And meeting all of the conditions below: * liver biopsy for histological evaluation of liver fibrosis * Length of liver biopsy ≥ 15 mm paraffin sections (except if cirrhosis) * Age of majority in their country * Obtaining the signature of consent for participation in the data collection, in addition to the routine consent form routinely used at the sites.
Exclusion criteria
* Cause of chronic liver disease other than viral (alcohol, hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...) and other than non-alcoholic fatty-liver disease * History of antiviral therapy for 6 months or less of current antiviral therapy * Any systemic, viral hepatitis and HIV co-infection * Pregnant woman * Failure to obtain consent * Length of all liver biopsy specimens below 15mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation coefficients between factors and liver stiffness | Within one year of the study start date | Factors include patient's clinical and biological parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rates depending on factors | Within one year of the study start date | Factors include patient's clinical and biological parameters |
| Diagnostic performance of multivariate models to assess liver fibrosis levels | Within one year of the study start date | 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: * at least significant fibrosis (Metavir score F≥2) * at least severe fibrosis (Metavir score F≥3) * liver cirrhosis (Metavir score F=4) |
| Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis | Within one year of the study start date | This will be determined by histological examination of liver biopsy |
Countries
Belgium, China, Denmark, France, Germany, Greece, Hong Kong, Italy, Romania
Outcome results
None listed