This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).
Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA. Therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
86
Seoul National University Hospital
Seoul, South Korea
Minimum diameter of ablative zone
Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.
Time frame: 7 days after RFA
Technical success rate
Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
Time frame: 1 month
IDR rate
Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA
Time frame: 24 months after RFA
EM rate
Cumulative extrahepatic metastasis (EM) rate over two years after RFA
Time frame: 24 months after RFA
1-year local tumor progression (LTP)
Comparison of rates of LTP in two groups in a year after RFA
Time frame: 12 months after RFA
2-year LTP
Comparison of rates of LTP in two groups in two years after RFA
Time frame: 24 months after RFA
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.