ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
- Conditions
- Liver Fibrosis
- Registration Number
- NCT02313649
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 447
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). Within 12 months of the study start date This will be determined by histological examination of liver biopsy
- Secondary Outcome Measures
Name Time Method 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). Within 12 months of the study start date This will be determined by histological examination of liver biopsy
Trial Locations
- Locations (15)
West China Hospital, Sichuan University
🇨🇳Chengdu, China
GuangZhou 8th People's Hospital
🇨🇳GuangZhou, China
3rd Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, China
People's Liberation Army General（301）Hospital
🇨🇳Beijing, China
YunNan Province Second People's Hospital
🇨🇳KunMing, China
Isolation Hospital, HeNan Province
🇨🇳ZhengZhou, China
1st Affiliated Hospital, ZheJiang University
🇨🇳HangZhou, China
Shengjing Hospital of Chinese Medical University
🇨🇳ShenYang, China
1st Affiliated Hospital, Haerbin Medical University
🇨🇳Haerbin, China
Shanghai 1st People's Hospital
🇨🇳Shanghai, China
1st Affiliated Hospital, Sun Yat-Sen University
🇨🇳GuangZhou, China
2nd Affiliated Hospital, Lanzhou University
🇨🇳LanZhou, China
1st Affiliated Hospital, XiAn Transportation University
🇨🇳XiAn, China
Xijing Hospital
🇨🇳XiAn, China
Jiangsu Provincial Hospital
🇨🇳NanJing, China