Clinical trial NCT02313649: ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
Official title: Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibrosis
Keywords: liver
fibrosis
elastography
ShearWave Elastography
ultrasound
Lead sponsor: SuperSonic Imagine
Sponsor class: INDUSTRY
First posted: 2014-12-10
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: Within 12 months of the study start date
Secondary outcomes:
measure: 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).
timeFrame: Within 12 months of the study start date
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Liberation Army General（301）Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: GuangZhou
country: China
facility: 1st Affiliated Hospital, Sun Yat-Sen University
city: Guangzhou
country: China
facility: 3rd Affiliated Hospital, Sun Yat-Sen University
city: GuangZhou
country: China
facility: GuangZhou 8th People's Hospital
city: Haerbin
country: China
facility: 1st Affiliated Hospital, Haerbin Medical University
city: HangZhou
country: China
facility: 1st Affiliated Hospital, ZheJiang University
city: KunMing
country: China
facility: YunNan Province Second People's Hospital
city: LanZhou
country: China
facility: 2nd Affiliated Hospital, Lanzhou University
city: NanJing
country: China
facility: Jiangsu Provincial Hospital
city: Shanghai
country: China
facility: Shanghai 1st People's Hospital
city: ShenYang
country: China
facility: Shengjing Hospital of Chinese Medical University
city: XiAn
country: China
facility: 1st Affiliated Hospital, XiAn Transportation University
city: XiAn
country: China
facility: Xijing Hospital
city: ZhengZhou
country: China
facility: Isolation Hospital, HeNan Province
Study officials:
affiliation: People's Liberation Army General（301）Hospital
name: Ping Liang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.