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ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B

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ClinicalTrials.gov Identifier: NCT02313649
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
SuperSonic Imagine

Brief Summary:
This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.

Condition or disease
Liver Fibrosis

Detailed Description:

Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique.

ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis.

This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard).

The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed.

Liver stiffness measurement made by the Aixplorer will also be compared to blood markers


Study Type : Observational
Actual Enrollment : 447 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection
Study Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4). [ Time Frame: Within 12 months of the study start date ]
    This will be determined by histological examination of liver biopsy


Secondary Outcome Measures :
  1. Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4). [ Time Frame: Within 12 months of the study start date ]
    This will be determined by histological examination of liver biopsy



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese patients with chronic viral hepatitis B admitted for the realization of an intercostal liver biopsy in defined investigator centers.
Criteria

Inclusion Criteria:

  • Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,
  • Patients having reached the age of majority in China,
  • Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion:

    • minimal length of biopsy samples of 15 mm, stored in paraffin
    • Minimal number of portal tracts of 6 per biopsy samples
  • Patients of Chinese ethnic origin

Exclusion Criteria:

  • Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection(Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)
  • History of antiviral therapy at any time
  • Any patient presenting with a co-infection of HIV
  • Any patient presenting with combined liver malignant tumor
  • Previous liver transplantation
  • Pregnant women
  • Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis…
  • Any patient combined with intrahepatic cholestasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313649


Locations
China
People's Liberation Army General(301)Hospital
Beijing, China
West China Hospital, Sichuan University
Chengdu, China
1st Affiliated Hospital, Sun Yat-Sen University
GuangZhou, China
3rd Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
GuangZhou 8th People's Hospital
GuangZhou, China
1st Affiliated Hospital, Haerbin Medical University
Haerbin, China
1st Affiliated Hospital, ZheJiang University
HangZhou, China
YunNan Province Second People's Hospital
KunMing, China
2nd Affiliated Hospital, Lanzhou University
LanZhou, China
Jiangsu Provincial Hospital
NanJing, China
Shanghai 1st People's Hospital
Shanghai, China
Shengjing Hospital of Chinese Medical University
ShenYang, China
1st Affiliated Hospital, XiAn Transportation University
XiAn, China
Xijing Hospital
XiAn, China
Isolation Hospital, HeNan Province
ZhengZhou, China
Sponsors and Collaborators
SuperSonic Imagine
Investigators
Principal Investigator: Ping Liang People's Liberation Army General(301)Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SuperSonic Imagine
ClinicalTrials.gov Identifier: NCT02313649     History of Changes
Other Study ID Numbers: LE2
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by SuperSonic Imagine:
liver
fibrosis
elastography
ShearWave Elastography
ultrasound

Additional relevant MeSH terms:
Fibrosis
Hepatitis B
Liver Cirrhosis
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases