Diagnosis of Nodules ≤2 cm Based on US and CEUS Compared With Current Clinical Procedure
- Conditions
- Liver CirrhosisLiver Cancer
- Interventions
- Diagnostic Test: Immediate CEUS
- Registration Number
- NCT05360420
- Lead Sponsor
- Tianjin Third Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6730
- Patients are at high risk of HCC.
- The ages of patients are between 18 and 80.
- Patients are with solid liver lesion(s) ≤ 2 cm detected by US.
- Patient signs the informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate CEUS group Immediate CEUS CEUS (SonoVue) was performed immediately after routine US screening of suspicious lesions. The lesions were classified according to CEUS examination by the diagnosing physician, including consideration of HCC, suspected HCC, and benign lesions. Further hepatobiliary-specific MRI (Modis/Primexian) was performed for lesions considered HCC or suspicious for HCC, and benign lesions were followed up. The diagnostic findings of hepatobiliary-specific MRI were classified by the diagnosing physician and included consideration of HCC, suspected HCC, and benign lesions. For hepatobiliary-specific MRI lesions considered HCC or suspicious for HCC, pathological examination was performed, and benign lesions were followed up.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Tianjin Third Central Hospital
🇨🇳Tianjin, Tianjin, China