Screening and Diagnosis of Nodules ≤2 cm in High-risk HCC Patients in China Based on US and CEUS: a Multicenter, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,730
- 试验地点
- 1
- 主要终点
- Diagnostic performance based on US and immediate CEUS with current routine
研究概览
简要总结
Due to different etiologies, diagnosis and treatment of HCC in China is different from that in Western countries.US is an important screening method for HCC in patients with liver cirrhosis. CEUS, as an enhanced imaging method based on US, has the advantages of convenience, non-radiation, low cost, short examination time, and the diagnostic performance of HCC is comparable to that of CECT, CEMRI, and hepatobiliary-specific MRI.
It is of great significance to consider the cost-effectiveness of each examination based on the principle of cost minimization. Therefore, we propose immediate CEUS examination for suspicious lesions ≤2 cm screened by US, and determine the diagnostic process of further diagnostic methods based on the CEUS results. The aim of this study is to establish a screening and diagnosis process for HCC ≤2 cm suitable for China considering time effect, economic effect and diagnostic efficiency.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are at high risk of HCC.
- •The ages of patients are between 18 and
- •Patients are with solid liver lesion(s) ≤ 2 cm detected by US.
- •Patient signs the informed consent.
排除标准
- •Patients are with liver cirrhosis due to congenital hepatic fibrosis or due to hepatic vascular diseases such as hereditary telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion syndrome, congestive heart disease.
- •Patient's age is < 18 years old or > 80 years old.
- •Patients with known hypersensitivity to CEUS, CECT, CEMRI, or hepatobiliary-specific MRI contrast agents.
- •Patient is a pregnant or breastfeeding woman.
- •Patient is not diagnosed based on the reference diagnostic criteria required by the study.
- •Patient is considered to be unsuitable to participate in the study.
结局指标
主要结局
Diagnostic performance based on US and immediate CEUS with current routine
时间窗: 6 to 12 months
The diagnostic efficacy，including sensitivity, specificity, accurary and AUC， of the two groups for HCC from the detection of suspicious lesions by routine US screening to the final diagnosis.
Time benefits based on US and immediate CEUS with current routine
时间窗: 6 to 12 months
Time from the detection of suspicious lesions by routine US screening to the first diagnosis of HCC by enhanced imaging examinations and the final diagnosis of HCC.
次要结局
- The economic benefit based on US and immediate CEUS with current routine(6 to 12 months)