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临床试验/NCT04920214
NCT04920214Unknown不适用

Application Value of CEUS Li-RADS in Hepatic Focal Lesions in Patients With Non-high Risk Factors for Hepatocellular Carcinoma

Second Affiliated Hospital, School of Medicine, Zhejiang University10 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
10
主要终点
Specificity

研究概览

简要总结

Currently, there are few studies on the diagnostic ability of CEUS-LI-RADS in patients with non-high risk factors for liver nodules. Whether this classification is applicable to such patients remains controversial. There are relatively few studies on the diagnostic efficacy of HCC in clinical diagnosis and the consistency between map readers, and the applicable population is only focused on patients with hepatic fibrosis. Therefore, this study explored the application value of CEUS Li-RADS in liver focal lesions in patients with non-high risk factors for hepatocellular carcinoma.

详细描述

According to the latest epidemiological survey in 2018, primary liver cancer is the sixth most common cancer in the world. Among these, hepatocellular carcinoma is the most common type of liver cancer. Clinicians' diagnosis of HCC has been gradually transformed from invasive puncture diagnosis to non-invasive diagnosis based on enhanced imaging findings. In HCC tissue, the number of small blood vessels was increased and the arrangement was disordered. Compared with the surrounding normal liver tissue, there were more obvious manifestations of increased arterial blood supply. Contrast-enhanced Ultrasound (CEUS) is the most sensitive and objective tool for detecting circulatory perfusion, and can achieve a clear and dynamic display of low speed and small blood flow. Its diagnostic efficacy of HCC is similar to the diagnostic ability of Enhanced CT.

In order to better standardize the writing of liver CEUS report by sonographers, and to facilitate sonographers and clinicians to reach a consensus on the diagnosis and treatment of liver lesions, In 2017, the American Radiology College (ACR) released the CEUS-based Liver Imaging Reporting and Data System (CEUS-Li-RADS). At the same time, according to the perfusion methods in the arterial, portal and venous phases, the CEUS-Li-RADS angiographic findings were classified into main features and LR-M features by ACR Association. The former included high enhancement in arterial phase and mild clearance in portal vein phase (after 60S) or delayed phase. The latter includes annular high enhancement, early clearance and complete clearance. In the classification, CEUS Li-RADS was classified into the following categories according to the possibility of HCC diagnosis with different characteristics of CEUS: LR-1 (definitely benign), LR-2 (possibly benign),LR-3 (possibly HCC), LR-4 (highly suspected HCC), LR-5 (confirmed HCC), and LR-M (liver malignant lesion, not specifically HCC).

In January 2018, Professor Bruix, Chairman of AASLD, wrote in the journal Heaptology that a qualified LIRADS classification should meet the following requirements :(1) LIRADS classification should focus on high-risk groups for HCC; (2) In LI-RADS classification, the specificity of LR-5 in the diagnosis of HCC should be close to 100%; (3) There is a good consistency between the main evaluation criteria of LI-RADS classification, LR-M evaluation criteria and the readers of final classification.

Currently, there are few studies on the diagnostic ability of CEUS-LI-RADS in patients with non-high risk factors for liver nodules. Whether this classification is applicable to such patients remains controversial. There are relatively few studies on the diagnostic efficacy of HCC in clinical diagnosis and the consistency between map readers, and the applicable population is only focused on patients with hepatic fibrosis. Therefore, this study explored the application value of CEUS Li-RADS in liver focal lesions in patients with non-high risk factors for hepatocellular carcinoma.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The patient showed focal liver lesions on routine ultrasound examination.
  • •Non-HCC high-risk patients (hepatitis B, cirrhosis)

排除标准

  • •High-risk patients with HCC (hepatitis B, cirrhosis);
  • •Patients with solid liver tumors could not be found by conventional imaging;
  • •Patients who do not sign informed consent;

结局指标

主要结局

Specificity

时间窗: 3 years

The specificity of LR-5 diagnosis of HCC was compared among different map readers

Positive Predictive Value

时间窗: 3 years

The positive predictive value of LR-5 diagnosis of HCC was compared among different map readers

Negative Predictive Value

时间窗: 3 years

The negative predictive value of LR-5 diagnosis of HCC was compared among different map readers

Sensitivity

时间窗: 3 years

The sensitivity of LR-5 diagnosis of HCC was compared among different map readers

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (10)

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