Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis
研究概览
简要总结
This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.
详细描述
The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography® by comparison with liver histology, serum marker or FibroScan® in chronic hepatitis B or C patients.Real-time Tissue Elastography®, biopsy and serum maker are performed.
If in the hospital they can perform FibroScan®, FobroScan® also be performed. The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. The time between the Real-time Tissue Elastography® , biopsy, blood sampling and FiroScan® must not exceed four weeks.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female and at least 20 years of age
- •Chronic hepatitis B or Chronic hepatitis C
- •Subject is willing to fast for 8 hours prior to each study visit
排除标准
- •History of alcohol abuse (alcohol intake > 20g/day)
- •Evidence or history of chronic hepatitis not caused by HBV or HCV
- •During 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed.
- •Pregnant or lactating patients
- •Contraindications of liver biopsy or liver resection
结局指标
主要结局
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis
时间窗: one year
To evaluate the correlation between Real-time Tissue Elastography® index and histological diagnosis (the gold standard for liver fibrosis), we calculate sensitivity and specificity, ROC curves. Sensitivity, specificity and ROC curves obtained under below stiations: 1. liver fibrosis index diagnose of histological diagnosis F4 2. liver fibrosis index diagnose of histological diagnosis F3 or greater 3. liver fibrosis index diagnose of histological diagnosis F2 or greater
次要结局
- Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker(one year)
- Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan®(one year)