Strategy for Accurate Diagnosis by Contrast‐Enhanced Ultrasound of Focal Liver Lesions in Patients Not at High Risk for Hepatocellular Carcinoma

Objective To develop an effective strategy for accurate diagnosis of focal liver lesions (FLLs) in patients with non‐high risk for hepatocellular carcinoma (HCC). Methods From January 2012 to December 2015, consecutive patients with non‐high risk for HCC who underwent contrast‐enhanced ultrasound (CEUS) were included in this retrospective double‐reader study. All patients were stratified into 2 different risks (intermediate, low‐risk) groups according to criteria based on clinical characteristics, known as clinical risk stratification criteria. For the intermediate‐risk group, the CEUS criteria for identifying benign lesions and HCCs were constructed based on selected CEUS features. The diagnostic performance of the clinical risk stratification criteria, and CEUS criteria for identifying benign lesions and HCCs was evaluated. Results This study included 348 FLLs in 348 patients. The sensitivity and specificity of the clinical risk stratification criteria for malignancy was 97.8 and 69.8%. Patients were classified as intermediate risk if they were male, or older than 40 years of age, or HBcAb positive, or having positive tumor markers. Otherwise, patients were classified as low risk. Among the 348 patients, 327 were in the intermediate‐risk group and 21 were in the low‐risk group. In the intermediate‐risk group, the CEUS criteria for identifying benign lesions were any of the following features: 1) hyper/isoenhancement in the arterial phase without washout, 2) nonenhancement in all phases, 3) peripheral discontinuous globular enhancement in the arterial phase, 4) centrifugal enhancement or peripheral enhancement followed by no central enhancement, or 5) enhanced septa. The accuracy, sensitivity, and specificity of the CEUS criteria for identifying benign lesions were 94.5, 83.0, and 99.6%, respectively. Arterial phase hyperenhancement followed by mild and late washout (>60 seconds) was more common in HCC patients than in non‐HCC patients (P