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 ...
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. Zusammenfassung Hintergrund Diese prospektive, multizentrische, DEGUM-geforderte Studie untersucht die diagnostische Genauigkeit standardisierter Algorithmen fur die Kontrastmittelsonografie (CEUS-Algorithmen) in der nichtinvasiven Diagnostik des hepatozellularen Karzinoms (HCC) bei Hochrisikopatienten. Methoden HCC-Hochrisikopatienten mit histologisch gesicherter Leberlasion im B-Bild-Ultraschall wurden prospektiv multizentrisch eingeschlossen. Klinische Daten und Bildgebungsbefunde wurden uber Online-Eingabemasken erfasst. Es erfolgte ein direkter Vergleich der diagnostischen Genauigkeiten fur die konventionelle CEUS-Befundung zum Untersuchungszeitpunkt (CEUS-on-site) und die CEUS-Algorithmen ESCULAP (Erlanger Synopsis for Contrast-enhanced Ultrasound for Liver lesion Assessment in Patients at risk) und CEUS LI-RADS (Contrast-Enhanced UltraSound Liver Imaging Reporting and Data System). Ergebnisse 321 Patienten an 43 Zentren wurden eingeschlossen (93,1% Leberzirrhose). Der histologische Befund ergab 256 HCCs und 23 intrahepatische cholangiozellulare Karzinome (iCCA). Die hochste Sensitivitat bei Zirrhose-Patienten (n=299) erzielten der CEUS-Algorithmus ESCULAP (94,2%) und CEUS-on-site (90,9%), die geringste Sensitivitat der CEUS LI-RADS-Algorithmus (64%; p<0,001). Die Spezifitat war hoher fur CEUS LI-RADS (78,9%) versus ESCULAP (50,9%) und CEUS on-site (64,9%; p<0,001). Der negativ pradiktive Wert (NPW) war fur CEUS LI-RADS niedriger als fur ESCULAP (34,1% vs. 67,4%; p<0,001) und CEUS-on-site (62,7%; p<0,001). Der positiv pradiktive Wert (PPW) war fur alle Modalitaten hoch (rund 90%). Schlussfolgerungen Dies ist die erste prospektive, multizentrische Studie zum Vergleich der standardisierten Kontrastmittelsonografie mit den kurzlich entwickelten CEUS-Algorithmen in histologisch gesicherten Leberlasionen bei Zirrhose-Patienten. Unsere Ergebnisse bestatigen die exzellente diagnostische Genauigkeit der Kontrastmittelsonografie in der nichtinvasiven HCC-Diagnostik bei Hochrisikopatienten. Die On-site-Diagnose eines erfahrenen Untersuchers erzielt dabei eine beinahe ebenso gute diagnostische Genauigkeit wie die CEUS-basierten Diagnosealgorithmen
; Kunze, Georg ; Leitlein, Jens ; Link, Alexander 
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