NCT00822991Unknown不适用
Sonazoid Enhanced Liver Cancer Trial for Early Detection
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 760
- 试验地点
- 2
- 主要终点
- Size of HCC which is detected first
研究概览
简要总结
The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age over 20
- •HBV or HCV related liver cirrhosis
- •No history of HCC
- •Diagnosed as liver cirrhosis histologically or clinically Histologically confirmed by liver biopsy Confirmed by formula of diagnosing cirrhosis Radiological finding Finding of portal hypertension Platelet<130,000
- •Inpatient or outpatient
- •Patients who signed a written informed consent form
排除标准
- •History of hypersensitivity to egg yolk
- •Pregnant or lactating women and women who may be pregnant
- •Severe liver dysfunction(AST, ALT,or BIL level >10ULN
- •Associated with HCC
- •Patients receiving interferon
- •Age under 20
- •Judged by investigator not to be appropriate for inclusion in this study
结局指标
主要结局
Size of HCC which is detected first
时间窗: 10 years
次要结局
- Time to detection of HCC(10 years)
- The improvement of prognosis of patients who are diagnosed in this study(10 years)
研究者
研究点 (2)
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