Abstract
To investigate the safety and the efficacy of RFA guided by contrast-enhanced ultrasound (CEUS) with perflubutane, we conducted a post-marketing surveillance on the subjects undergoing RFA on hepatic lesions with (SZ group) or without (C group) CEUS guide. We collected CRFs from 328 subjects as SZ group and 340 subjects as C group, and adverse events (AE) were reported 67.1%, 69.3% respectively. Nausea and vomiting were reported as adverse reactions from a subject in SZ group. There were no difference between two groups on the incidence and variety of AEs. Overall efficacy as RFA guide was 90.9%, visual improvement of lesions was 75.0%. Moreover, RFA success rate in the lesions of which visual confirmation of lesion in B mode were insufficient was significantly higher in SZ group. Perflubutane could be used as CEUS guide for RFA safely, and it was demonstrated that visual improvement by CEUS improves RFA success rate.
