the Department of Medical Ultrasound, Third Affiliated Hospital of Sun Yat-Sen University
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 460
- 主要终点
- Degree of Liver Fibrosis
研究概览
简要总结
This national multicenter prospective study is aimed to study the diagnositic performance of STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B infection.
详细描述
Ultrasound liver elasticity measurement and imaging has not only been proposed as an alternative to evaluate the severity of chronic liver fibrosis, but also as a mean to stratify patients with advanced fibrosis according to risks of occurrence of clinical complications of end-stage liver diseases.
Sound touch elastography (STE）and sound touch quantify (STQ) developed by Mindray Resona 7 imaging system provide both two-dimensional and point shear-wave elastography of tissue elasticity with stronger penetration and easy operation.
This analysis will study the diagnositic performance of STE/STQ elastography for lver fibrosis and the prognostic value of STE/STQ elastography for the prediction of clinical complications of chronic liver diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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 STE/STQ 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 of the conditions below will exclude patients from the study:
- •Any patient presenting with combined etiologies of chronic liver diseases:，including Non hepatitis B viral infection（Hepatitis A, C, D, E）, alcoholic chronic liver disease, hemochromatosis, autoimmune hepatitis，etc
- •Any patient presenting with a co-infection of HIV
- •Any patient presenting with combined liver tumor
- •Any patient ever received liver transplantation
- •Pregnant women
- •Acute hepatitis
结局指标
主要结局
Degree of Liver Fibrosis
时间窗: 1-2 years
All liver biopsies will be taken for evaluating the degree of liver fibrosis according to the METAVIRE classification. The degree of fibrosis is classified in a 0-4 scale as follows: F0: no fibrosis, F1: portal fibrosis alone, F2: portal fibrosis with rare septa, F3: portal fibrosis with many septa, and F4: cirrhosis.
次要结局
- Complication rates depending on liver STE/STQ measurement values at baseline(2 years)
研究者
Rongqin Zheng
the Department of Medical Ultrasound
Third Affiliated Hospital, Sun Yat-Sen University