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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TICW-RFA | Active Comparator | Bipolar RFA using twin internally cooled-wet electrodes |
|
| SC-RFA | Active Comparator | Switching monopolar RFA using separable clustered electrodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar RFA | Device | Bipolar RFA in which RF currents flow between two electrodes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum diameter of ablation zone per unit time | Minimum diameter of ablative zone per unit time on post-RFA CT or MRI in a mm. | 3 days after RFA |
| Measure | Description | Time Frame |
|---|---|---|
| Technique efficacy | Technical success on 1 month follow-up imaging after RFA (no residual/progressed tumor) | 1 month after RFA |
| IDR rate | Cumulative intrahepatic distant recurrence (IDR) rate over 2 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32986758 | Derived | Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. 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. PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020. |
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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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| SM-RFA |
| Device |
Monopolar RFA using multiple electrodes with switching mode |
|
| Twin internally cooled-wet electrodes | Device | 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 |
|
|
| 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. |
|
|
| 12 months, 24 months after RFA |
| EM rate | Cumulative extrahepatic metastasis (EM) rate over 2 years after RFA | 12 months, 24 months after RFA |
| Local tumor progression (LTP) | Cumulative LTP rates in two groups in 2 years after RFA | 12 months, 24 months after RFA |
Volume of ablative zone on post-RFA CT or MRI in a mm3
| 3 days after RFA |
| Ablation time | RFA procedure time in each patient. | 1 day |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |