Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 447
- 试验地点
- 15
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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).
时间窗: Within 12 months of the study start date
This will be determined by histological examination of liver biopsy
次要结局
- 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)