Clinical trial NCT02181452: Liver Fibrosis Assessment With ShearWave Elastography
Official title: Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibrosis
Keywords: liver
fibrosis
ShearWave Elastography
ultrasound
Lead sponsor: SuperSonic Imagine
Sponsor class: INDUSTRY
Collaborators: name: Johann Wolfgang Goethe University Hospital
First posted: 2014-07-04
Enrollment: 2333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation coefficients between factors and liver stiffness
timeFrame: Within one year of the study start date
Secondary outcomes:
measure: Technical success rates depending on factors
timeFrame: Within one year of the study start date
measure: Diagnostic performance of multivariate models to assess liver fibrosis levels
timeFrame: Within one year of the study start date
measure: Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis
timeFrame: Within one year of the study start date
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University of Antwerp
city: Guangzhou, Guangdong
country: China
facility: 3rd Hospital of Sun Yat-sen University
city: Odense
country: Denmark
facility: Odense University Hospital
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Clichy
country: France
facility: Beaujon Hospital
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Paris
country: France
facility: Cochin Hospital
city: Bonn
country: Germany
facility: University of Bonn
city: Frankfurt
country: Germany
facility: Johan Goethe Universitat
city: Athens
country: Greece
facility: University of Athens Medical School
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong - Prince of Wales Hospital
city: Pavia
country: Italy
facility: University of Pavia
city: Timisoara
country: Romania
facility: University of Timosoara
Study officials:
affiliation: Johan Goethe University
name: Mireen Freidrich-Rust
role: PRINCIPAL_INVESTIGATOR
References: