Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Cumulative incidence of carcinogenesis of hepatocellular carcinoma
研究概览
简要总结
This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.
详细描述
The aim of this study is to validate the predictive value of Real-time Tissue Elastography® by comparison with serum marker or FibroScan® in chronic hepatitis B or C patients.
Every year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed.
Subjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months.
The time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy 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
排除标准
- •Evidence or history of hepatocellular carcinoma
- •History of alcohol abuse (alcohol intake > 20g/day)
- •Pregnant or lactating patients
- •Psychosis
结局指标
主要结局
Cumulative incidence of carcinogenesis of hepatocellular carcinoma
时间窗: every four or six months
Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais
次要结局
- Cancer-free survival(every four or six months)
- Overall survival(one year)
- The cumulative incidence and severity of gastro-esophageal varices(one year)
- The cumulative incidence and severity of decompensated cirrhosis(one year)