Liver Fibrosis Assessment With ShearWave Elastography

Liver Fibrosis Clinical Trial

Official title:

Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181452
• Other study ID #: LE1
• Status: Completed
• Phase: N/A
• First received: June 19, 2014
• Last updated: May 11, 2015
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: SuperSonic Imagine
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2333
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
Belgium	University of Antwerp	Edegem
China	3rd Hospital of Sun Yat-sen University	Guangzhou, Guangdong
Denmark	Odense University Hospital	Odense
France	University Hospital of Bordeaux	Bordeaux
France	Beaujon Hospital	Clichy
France	Hopital Edouard Herriot	Lyon
France	Cochin Hospital	Paris
Germany	University of Bonn	Bonn
Germany	Johan Goethe Universitat	Frankfurt
Greece	University of Athens Medical School	Athens
Hong Kong	Chinese University of Hong Kong - Prince of Wales Hospital	Hong Kong
Italy	University of Pavia	Pavia
Romania	University of Timosoara	Timisoara

Sponsors (2)

Lead Sponsor	Collaborator
SuperSonic Imagine	Johann Wolfgang Goethe University Hospitals

Countries where clinical trial is conducted

Belgium,  China,  Denmark,  France,  Germany,  Greece,  Hong Kong,  Italy,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation coefficients between factors and liver stiffness	Factors include patient's clinical and biological parameters	Within one year of the study start date	No
Secondary	Technical success rates depending on factors	Factors include patient's clinical and biological parameters	Within one year of the study start date	No
Secondary	Diagnostic performance of multivariate models to assess liver fibrosis levels	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)	Within one year of the study start date	No
Secondary	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	No