Real-life assessment of standardized contrast-enhanced ultrasound (CEUS) and CEUS algorithms (CEUS LI-RADS${}^{\circledR }$/ESCULAP) in hepatic nodules in cirrhotic patients. A prospective multicenter study

Hepatocellular carcinoma (HCC) can be diagnosed non-invasively with contrast-enhanced ultrasound (CEUS) in cirrhosis if the characteristic pattern of arterial phase hyperenhancement followed by hypoenhancement is present. Recent studies suggest that diagnosis based on this ''hyper-hypo'' pattern needs further refinement. This study compares the diagnostic accuracies of standardized CEUS for HCC according to the current guideline definition and following the newly developed CEUS algorithms (CEUS LI-RADS${}^{\circledR }$, ESCULAP) in a prospective multicenter real-life setting. Cirrhotic patients with liver lesions on B-mode ultrasound were recruited prospectively from 04/2018 to 04/2019, and clinical and imaging data were collected. The CEUS standard included an additional examination point after 4-6 min in case of no washout after 3 min. The diagnostic accuracies of CEUS following the guidelines (''hyper-hypo'' pattern), based on the examiner's subjective interpretation (''CEUS subjective''), and based on the CEUS algorithms ESCULAP and CEUS LI-RADS${}^{\circledR }$ were compared. In total, 470 cirrhotic patients were recruited in 43 centers. The final diagnosis was HCC in 378 cases (80.4%) according to the reference standard (histology 77.4%, MRI 16.4%, CT 6.2%). The ''hyper-hypo'' pattern yielded 74.3% sensitivity and 63% specificity. ''CEUS subjective'' showed a higher diagnostic accuracy (sensitivity, 91.5%; specificity, 67.4%; positive predictive value, 92%; negative predictive value, 66%). Sensitivity was higher for ESCULAP (95%) and ''CEUS subjective'' (91.5%) versus CEUS LI-RADS${}^{\circledR }$ (65.2%; p < 0.001). Specificity was highest for CEUS LI-RADS${}^{\circledR }$ (78.6%; p < 0.001). CEUS has an excellent diagnostic accuracy for the non-invasive diagnosis of HCC in cirrhosis. CEUS algorithms may be a helpful refinement of the ''hyper-hypo'' pattern defined by current HCC guidelines.