A Prospective Cohort Study to Compare Contrast Enhanced Liver CT and Ultrasonography for Hepatocellular Carcinoma Surveillance in High-risk Group of HCC: Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Detection rate of patients with HCC
研究概览
简要总结
The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC.
详细描述
Patients at high risk of HCC are recommended to undergo biannual surveillance using ultrasound. In this study, LDCT is performed in addition to biannual ultrasound surveillance in eligible patients to compare their sensitivity for HCC. Standard of reference would be follow-up imaging and/or gadoxetic acid-enhanced liver MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •All conditions have to be satisfied to be enrolled.
- •> 20 years
- •high risk group of HCC according to AASLD guideline
- •risk index > = 2.33
- •currently on regular biannual surveillance using ultrasonography
- •sign informed consent
排除标准
- •Patients with any of following condition cannot be enrolled.
- •previously diagnosed with HCC
- •any contraindication of contrast enhanced CT including allergic reaction to iodine
- •history of other malignancy
研究组 & 干预措施
High risk group of HCC
known high risk group of HCC according to AASLD guideline. And patients whose risk index is equal to or higher than 2.33.
Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus [HCV] or hepatitis B surface antigen [HBsAg] is positive).
Patients undergo ultrasonography and LDCT using non-ionic monomer iodinated CT contrast media biannually and the interval between ultrasound and LDCT is within 30 days.
干预措施: non-ionic monomer iodinated CT contrast media (Drug)
结局指标
主要结局
Detection rate of patients with HCC
时间窗: 18 months
from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening
次要结局
- False referral rate(18 months)
- Detection rate of patients with early HCC(18 months)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital