Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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). | This will be determined by histological examination of liver biopsy | Within 12 months of the study start date |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | This will be determined by histological examination of liver biopsy | Within 12 months of the study start date |
Not provided
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:
Patients of Chinese ethnic origin
Exclusion Criteria:
Not provided
Not provided
Not provided
Chinese patients with chronic viral hepatitis B admitted for the realization of an intercostal liver biopsy in defined investigator centers.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ping Liang | People's Liberation Army General(301)Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Liberation Army General(301)Hospital | Beijing | China | ||||
| West China Hospital, Sichuan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29730602 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |