Contrast-Enhanced Ultrasound for the Characterization of Malignant versus Benign Focal Liver Lesions in a Prospective Multicenter Experience - The SRUMB Study.

ABSTRACT

AIM: This study evaluated the accuracy of contrast-enhanced ultrasound (CEUS) for the differential diagnosis of benign vs. malignant focal liver lesions (FLL) in a real-life, multicenter experience. METHODS: This prospective study, including 14 Romanian centers, was performed over a 6 year period (February 2011- April 2017) and included 2062 FLLs assessed by CEUS. Inclusion criteria were newly diagnosed FLL on B-mode ultrasound, less than three lesions/patient, all FLLs evaluated by CEUS and by a second-line imaging technique (contrast enhanced CT or contrast enhanced MRI) or histology, considered as reference. The trial was registered in clinicaltrials.gov (Identifier NCT01329458). RESULTS: From the 2062 FLLs included in the study, 57.2% (1179) were malignant and 42.8% (883) were benign. CEUS had 83.9% sensitivity (Se), 97.8% specificity (Sp), 98.1% positive predictive value (PPV), 82.2% negative predictive value (NPV) and a diagnostic accuracy (Ac) of 89.9% for the positive diagnosis of malignant lesions. For the benign lesions, CEUS had 97.8% Se, 83.9% Sp, 82.2% PPV, 98.1% NPV 89.9% Ac. The diagnostic performance of CEUS for hepatocellular carcinoma was 76.6% Se, 98.4% Sp, and 91.2% Ac; for hemangioma 89.2% Se, 99% Sp, and 96.9% Ac and for metastases 90.9% Se, 98.4% Sp, and 96.9% Ac. CONCLUSIONS: CEUS proved a high accuracy in differentiating the malignant vs. benign character of a FLL. It can be confidently used as a first line imaging method in daily practice.