Liver Cancer, Liver Cirrhosis
Conditions
Keywords
Liver Cancer, CEUS, Diagnostic Methods, Cost Optimization
Brief summary
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.
Interventions
DIAGNOSTIC_TESTImmediate CEUS
Subjects will receive CEUS examination immediately for the suspicious lesion detected by US.
Sponsors
Tianjin Second People's Hospital
Tianjin Medical University Cancer Institute and Hospital
Peking University Binhai Hospital
Tianjin Nankai Hospital
Tianjin Medical University Second Hospital
Tianjin Medical University General Hospital
China-Japan Friendship Hospital
Beijing Hospital
Shanxi Province Cancer Hospital
Shanxi Provincial People's Hospital
The First Affiliated Hospital of Shanxi Medical University
Second Hospital of Shanxi Medical University
Shengjing Hospital
Hebei General Hospital
First Affiliated Hospital of Harbin Medical University
The Third Affiliated Hospital of Harbin Medical University
Tianjin Third Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance based on US and immediate CEUS with current routine | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The economic benefit based on US and immediate CEUS with current routine | 6 to 12 months | 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. |
Countries
China
Contacts
Primary ContactXiang Jing, MD
Backup ContactYan Zhou, MD
Outcome results
None listed