Seoul National University Hospital
Seoul, South Korea
NCT Number: NCT03699657
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).
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Monopolar RFA using dual switching mode (DSM)
Monopolar RFA using single switching mode (SSM)
A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
Other names: Octopus®
Time frame: 7 days after RFA
Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.
Time frame: 1 month
Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)
Time frame: 24 months after RFA
Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA
Time frame: 24 months after RFA
Cumulative extrahepatic metastasis (EM) rate over two years after RFA
Time frame: 12 months after RFA
Comparison of rates of LTP in two groups in a year after RFA
Time frame: 24 months after RFA
Comparison of rates of LTP in two groups in two years after RFA
Time frame: 1 month after RFA
Description and comparison of the type and incidence of major complication after RFA are assessed according to Society of Interventional Radiology (SIR) grading system in two groups.
Time frame: 7 days after RFA
Volume of ablative zone on post-RFA CT or MRI in a mm3.
Time frame: 1 day
RFA procedure time in each patient.
Time frame: 7 days after RFA
Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.
Seoul National University Hospital
Other
Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode
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