ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
NCT ID: NCT02313649
Last Updated: 2016-04-19
Study Results
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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COMPLETED
447 participants
OBSERVATIONAL
2014-12-31
2016-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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SuperSonic Imagine
INDUSTRY
Responsible Party
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Principal Investigators
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Ping Liang
Role: PRINCIPAL_INVESTIGATOR
People's Liberation Army General（301）Hospital
Locations
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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
Xi'an, , China
Xijing Hospital
Xi'an, , China
Isolation Hospital, HeNan Province
Zhengzhou, , China
Countries
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References
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Wang K, Lu X, Zhou H, Gao Y, Zheng J, Tong M, Wu C, Liu C, Huang L, Jiang T, Meng F, Lu Y, Ai H, Xie XY, Yin LP, Liang P, Tian J, Zheng R. Deep learning Radiomics of shear wave elastography significantly improved diagnostic performance for assessing liver fibrosis in chronic hepatitis B: a prospective multicentre study. Gut. 2019 Apr;68(4):729-741. doi: 10.1136/gutjnl-2018-316204. Epub 2018 May 5.
Other Identifiers
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LE2
Identifier Type: -
Identifier Source: org_study_id
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