Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)
研究概览
简要总结
The purpose of this study is to determine whether ultrasound or CT scanning is more effective at detecting early liver cancer in patients with advanced liver disease.
详细描述
Most cases of hepatocellular carcinoma (HCC) arise in patients with advanced liver disease, usually cirrhosis. Most patients with clinically evident HCC are not candidates for treatment with curative intent because of large tumor size, invasion of hepatic or portal veins, or metastatic disease. For this reason, screening for HCC at an asymptomatic and potentially curable stage in patients with advanced liver disease has been recommended by some authorities. Screening with various methods, of which ultrasound (US) and alpha-fetoprotein (AFP) have been the most extensively studied, has become accepted practice. Recently the technique of imaging the liver with or during both the hepatic arterial and portal venous phases of intravenous contrast ("liver-shuttle") has shown increased sensitivity in detecting HCCs compared to US.
The hypothesis of this study is that CT using a "liver-shuttle" protocol once a year is more sensitive and specific than US twice a year, both in combination with AFP for identification of potentially curable HCC in patients with cirrhosis. Patients will be randomized to "routine," accepted screening with hepatic US and AFP testing every 6 months or AFP testing every 6 months wtih triphasic CT every 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or cirrhosis
- •potential candidate for treatment of HCC
- •imaging study involving the liver in the last 12 months without evidence for HCC
- •must be a veteran in VISN 23
排除标准
- •active or untreated malignancy other than non-melanoma skin cancer
- •patients with advanced medical conditions such as severe cardiovascular disease, COPD, or severe end-stage liver disease
- •patients unable to receive intravenous contrast due to advanced kidney disease or severe allergy
- •history of liver mass identified on imaging study
结局指标
主要结局
Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)
时间窗: 6-12 months
Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations
次要结局
- Cost - Effectiveness of screening measure(1 year)