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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA with DSM mode | Active Comparator | RFA is performed in dual switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. |
|
| RFA with SSM mode | Active Comparator | RFA is performed in single switching mode using a separable clustered electrode (Octopus®) and a three-channel dual-generator unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSM | Device | Monopolar RFA using dual switching mode (DSM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum diameter of ablative zone | Minimum diameter of ablative zone on post-RFA CT or MRI in a mm. | 7 days after RFA |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor) | 1 month |
| IDR rate | Cumulative intrahepatic distant recurrence (IDR) rate over two years after RFA |
| Measure | Description | Time Frame |
|---|---|---|
| Complication | 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. | 1 month after RFA |
| Volume of ablative zone |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| SSM |
| Device |
Monopolar RFA using single switching mode (SSM) |
|
| Separable clustered electrodes | Device | 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. |
|
|
| 24 months after RFA |
| EM rate | Cumulative extrahepatic metastasis (EM) rate over two years after RFA | 24 months after RFA |
| 1-year local tumor progression (LTP) | Comparison of rates of LTP in two groups in a year after RFA | 12 months after RFA |
| 2-year LTP | Comparison of rates of LTP in two groups in two years after RFA | 24 months after RFA |
Volume of ablative zone on post-RFA CT or MRI in a mm3.
| 7 days after RFA |
| Ablation time | RFA procedure time in each patient. | 1 day |
| Maximal diameter of ablative zone | Maximal diameter of ablative zone on post-RFA CT or MRI in a mm. | 7 days after RFA |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |