Liver Fibrosis Assessment With ShearWave Elastography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No