Contrast-Enhanced Ultrasound Algorithms (CEUS-LIRADS/ESCULAP) for the Noninvasive Diagnosis of Hepatocellular Carcinoma – A Prospective Multicenter DEGUM Study

Abstract

Background This prospective multicenter study funded by the DEGUM assesses the diagnostic accuracy of standardized contrast-enhanced ultrasound (CEUS) for the noninvasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients. Methods Patients at high risk for HCC with a histologically proven focal liver lesion on B-mode ultrasound were recruited prospectively in a multicenter approach. Clinical and imaging data were entered via online entry forms. The diagnostic accuracies for the noninvasive diagnosis of HCC were compared for the conventional interpretation of standardized CEUS at the time of the examination (= CEUS on-site) and the two CEUS algorithms ESCULAP (Erlanger Synopsis for Contrast-enhanced Ultrasound for Liver lesion Assessment in Patients at risk) and CEUS LI-RADS (Contrast-Enhanced UltraSound Liver Imaging Reporting and Data System). Results 321 patients were recruited in 43 centers; 299 (93.1 %) had liver cirrhosis. The diagnosis according to histology was HCC in 256 cases, and intrahepatic cholangiocarcinoma (iCCA) in 23 cases. In the subgroup of cirrhotic patients (n = 299), the highest sensitivity for the diagnosis of HCC was achieved with the CEUS algorithm ESCULAP (94.2 %) and CEUS on-site (90.9 %). The lowest sensitivity was reached with the CEUS LI-RADS algorithm (64 %; p < 0.001). However, the specificity of CEUS LI-RADS (78.9 %) was superior to that of ESCULAP (50.9 %) and CEUS on-site (64.9 %; p < 0.001). At the same time, the negative predictive value (NPV) of CEUS LI-RADS was significantly inferior to that of ESCULAP (34.1 % vs. 67.4 %; p < 0.001) and CEUS on-site (62.7 %; p < 0.001). The positive predictive values of all modalities were high (around 90 %), with the best results seen for CEUS LI-RADS and CEUS on-site. Conclusion This is the first multicenter, prospective comparison of standardized CEUS and the recently developed CEUS-based algorithms in histologically proven liver lesions in cirrhotic patients. Our results reaffirm the excellent diagnostic accuracy of CEUS for the noninvasive diagnosis of HCC in high-risk patients. However, on-site diagnosis by an experienced examiner achieves an almost equal diagnostic accuracy compared to CEUS-based diagnostic algorithms.

Contrast-Enhanced Ultrasonography for Screening and Diagnosis of Hepatocellular Carcinoma: A Case Series and Review of the Literature

“…Additional societies worldwide also have guidelines for noninvasive diagnosis of HCC, including European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB), World Federation for Ultrasound in Medicine and Biology (WFUMB), and Erlanger Synopsis of Contrast-Enhanced Ultrasound for Liver Lesion Assessment in Patients at risk (ESCULAP), with studies comparing and contrasting them with LI-RADS. Schellhass et al recently completed a multicenter study comparing prospective diagnosis at the time of CEUS with retrospective categorizing lesions via ESCULAP and LIRADS guidelines [24]. This re-demonstrated accuracy of CEUS for noninvasive diagnosis of HCC and intrahepatic cholangiocarcinoma in cirrhotic patients and found that real-time diagnosis and ESCULAP had highest sensitivities, while LIRADS had superior sensitivity.…”

“…This re-demonstrated accuracy of CEUS for noninvasive diagnosis of HCC and intrahepatic cholangiocarcinoma in cirrhotic patients and found that real-time diagnosis and ESCULAP had highest sensitivities, while LIRADS had superior sensitivity. Negative predictive value of LIRADS was inferior, with positive predictive value similarly high among all three diagnostic categories [24] Within LI-RADS guidance, there is an additional category for malignant lesion that is not specific for HCC-LI-RADS M [18,19]. CEUS can provide crucial information that can be used to differentiate HCC from intrahepatic cholangiocarcinoma (ICC), by demonstrating differences in their enhancement patterns [23].…”

“…CEUS does have inherent limitations, many of which are shared with routine US. Accuracy depends on the operator with room for variability in interpretation and diagnosis [24]. CEUS also performs similarly to grayscale US where significant adiposity or advanced hepatic steatosis can cause limited visibility [13].…”

“…This re-demonstrated accuracy of CEUS for noninvasive diagnosis of HCC and intrahepatic cholangiocarcinoma in cirrhotic patients and found that real-time diagnosis and ESCULAP had highest sensitivities, while LIRADS had superior sensitivity. Negative predictive value of LIRADS was inferior, with positive predictive value similarly high among all three diagnostic categories [ 24 ]…”

Nachlese 43. Dreiländertreffen 2019 in Leipzig

“…CEUS-LI-RADS) ergab Vorteile bei der Treffsicherheit und Sensitivität zugunsten der ESCULAP-Klassifikation bei höherer Spezifität der CEUS-LI-RADS [17]. Im Juli 2020 wurden die Ergebnisse der Studien auch online als Fullpaper publiziert [18].…”