Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure

Tianjin Third Central Hospital6,730 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

6,730

Conditions

Liver Cancer Liver Cirrhosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients are at high risk of HCC. 2. The ages of patients are between 18 and 80. 3. Patients are with solid liver lesion(s) ≤ 2 cm detected by US. 4. Patient signs the informed consent. Exclusion Criteria: 1. 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. 2. Patient's age is \< 18 years old or \> 80 years old. 3. Patients with known hypersensitivity to CEUS, CECT, CEMRI, or hepatobiliary-specific MRI contrast agents. 4. Patient is a pregnant or breastfeeding woman. 5. Patient is not diagnosed based on the reference diagnostic criteria required by the study. 6. Patient is considered to be unsuitable to participate in the study.

Outcomes

Primary Outcomes

Diagnostic performance based on US and immediate CEUS with current routine

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 frame: 6 to 12 months

Time benefits based on US and immediate CEUS with current routine

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.

Time frame: 6 to 12 months

Secondary Outcomes

The economic benefit based on US and immediate CEUS with current routine

The cost of imaging studies from the discovery of suspicious lesions by routine US screening to the final clinical diagnosis of HCC or the clinical diagnosis of benign lesions.

Time frame: 6 to 12 months

Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts