Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 523
- 试验地点
- 2
- 主要终点
- Detection rate of early stage HCC
研究概览
简要总结
B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent for ultrasonography, has reported to have superior sensitivity in detecting focal liver lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So our aim is to compare the detection rate of early stage HCC and false referral rate of HCC between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%) than that of B-mode US (3%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Patient 20 years old or older,
- •Patient at high risk of HCC and is supposed to take ultrasonography,
- •Patient who has no suspicious HCC on previous examinations or patient who undergoes the first surveillance,
- •Patient who has liver cirrhosis proven by one of the following methods-liver biopsy (METAVIR score 4), identification of esophageal or gastric varix by endoscopically or radiologically, surface nodularity on ultrasonography, CT or MRI, platelet count less than 100,000/mm3, serum albumin less than 3.5 g/dl, or prothrombin time higher than 1.3 INR,
- •Patient without contraindication for sonazoid,
- •Patient willing to sign the informed consent
排除标准
- •Patient on pregnancy or breast feeding,
- •Patient with allergy to egg,
- •Patient with left-to-right shunt, respiratory insufficiency, or severe pulmonary hypertension,
- •Patient with history of HCC,
- •Patient with history of malignancy other than HCC -
研究组 & 干预措施
single arm
干预措施: Sonazoid-enhanced ultrasonography (Other)
结局指标
主要结局
Detection rate of early stage HCC
时间窗: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US
Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100
False referral rate of HCC
时间窗: 30±30 days after S-US if there is one or more suspicious HCC detected on S-US, or 180±30 days after S-US if there is no suspicious HCC detected on S-US
False referral rate of HCC =
次要结局
未报告次要终点