Liver Fibrosis Assessment With ShearWave Elastography
- Conditions
- Liver Fibrosis
- Registration Number
- NCT02181452
- Lead Sponsor
- SuperSonic Imagine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2333
-
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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation coefficients between factors and liver stiffness Within one year of the study start date Factors include patient's clinical and biological parameters
- Secondary Outcome Measures
Name Time Method 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
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)Technical success rates depending on factors Within one year of the study start date Factors include patient's clinical and biological parameters
Trial Locations
- Locations (13)
University of Antwerp
🇧🇪Edegem, Belgium
University of Timosoara
🇷🇴Timisoara, Romania
Cochin Hospital
🇫🇷Paris, France
University of Bonn
🇩🇪Bonn, Germany
University of Pavia
🇮🇹Pavia, Italy
Odense University Hospital
🇩🇰Odense, Denmark
University Hospital of Bordeaux
🇫🇷Bordeaux, France
Johan Goethe Universitat
🇩🇪Frankfurt, Germany
Beaujon Hospital
🇫🇷Clichy, France
3rd Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Hopital Edouard Herriot
🇫🇷Lyon, France
University of Athens Medical School
🇬🇷Athens, Greece
Chinese University of Hong Kong - Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong