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Bipolar RFA using twin internally cooled-wet electrodes

Switching monopolar RFA using separable clustered electrodes

Bipolar RFA in which RF currents flow between two electrodes

Bipolar RFA

Monopolar RFA using multiple electrodes with switching mode

SM-RFA

Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity

Twin internally cooled-wet electrodes

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.

Separable clustered electrodes

Jeong Min Lee, MD

This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.

Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC

Radiofrequency Ablation Using Internally Cooled Wet Electrodes in Bipolar Mode for the Treatment of Recurrent Hepatocellular Carcinoma After Locoregional Treatment: A Randomized Prospective Comparative Study

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.

Volume of ablative zone on post-RFA CT or MRI in a mm3

Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm.

Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor)

Cumulative intrahepatic distant recurrence (IDR) rate over 2 years after RFA

Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA

Cumulative LTP rates in two groups in 2 years after RFA

Seoul National University Hospital

Professor

Hematinics

Liver Extracts

Enrolled patients in the prospective study (RFA using separable clustered electrodes (Octopus®)) for treatment-naive HCC (n=79)

Patients who received RFA according to routine protocol in our center (multiple internally-cooled electrodes) for treatment-naive HCC from Jan 2011 to July 2013 in our institution (n=74) .

patients who signed informed consent, RFA was performed using separable clustered electrodes (Octopus®) in which, inter-tine distances can be flexibly adjusted by an operator.

The purpose of this study is to compare the therapeutic outcomes and safety of the study patients who received radiofrequency ablation (RFA) using separable clustered electrodes with those of a matched historical control group who had received RFA using multiple internally-cooled electrodes.

Although RFA is widely used as a curative treatment option for a variety of liver malignancies, it is generally limited for treating tumors larger than 2 cm in diameter with a sufficient tumor-free margin. Thus, various strategies are employed to create a sufficient ablation zone such as internally cooled-electrodes, expandable electrodes and adaptation of switching mono/bipolar controllers. Despite that these attempts have created larger ablative zones in clinical and preclinical studies, the efficacy should be validated in terms of clinical outcome.

In this study, investigators evaluated the therapeutic outcomes and safety of RFA using separable clustered electrodes for treatment-naive hepatocellular carcinomas (HCCs) in comparison with RFA using multiple internally-cooled electrodes. The study group is a subgroup of our prospective study cohort (NCT02683538) and a control group is a matched historical group received RFA in our institution using multiple internally-cooled electrodes.

Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study

Prospective, Single-center, Single-arm, Clinical Trial Evaluating the Clinical Efficacy and Safety of a Novel Separable Cluster Electrode in Patients With Focal Liver Malignancies

comparison of rates of sufficient ablative zone creation which covers the whole tumor on post-RFA computed tomography (CT) in each group

Comparison of rates of LTP in two groups in a year after RFA

Comparison of rates of LTP in two groups in two years after RFA

Comparison of rates of LTP in two groups in three years after RFA

comparison of survival rate without disease progression in two groups

RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit.

Monopolar RFA using dual switching mode (DSM)

Monopolar RFA using single switching mode (SSM)

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.

Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC

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

Volume of ablative zone on post-RFA CT or MRI in a mm3.

Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.

Minimum diameter of ablative zone on post-RFA CT or MRI in a mm.

Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA

Cumulative extrahepatic metastasis (EM) rate over two years after RFA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC	NCT03806218	Hepatocellular ...	Bipolar RFA SM-RFA Twin internally... Separable clust...	20 Years - 80 Years	Seoul National University Hospital
Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study	NCT02745483	Hepatocellular ...	Separable clust...	20 Years -	Seoul National University Hospital
Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up Study	NCT02745483	Hepatocellular ...	Separable clust...	20 Years -	Seoul National University Hospital
Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC	NCT03806218	Hepatocellular ...	Bipolar RFA SM-RFA Twin internally... Separable clust...	20 Years - 80 Years	Seoul National University Hospital
Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC	NCT03699657	Hepatocellular ...	DSM SSM Separable clust...	20 Years - 80 Years	Seoul National University Hospital
Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC	NCT03699657	Hepatocellular ...	DSM SSM Separable clust...	20 Years - 80 Years	Seoul National University Hospital

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