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| Name | Class |
|---|---|
| RF medical | UNKNOWN |
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To investigate the therapeutic effects and treatment results of radiofrequency ablation using combined bipolar and monopolar energy deliver with twin cooled-wet electrodes for recurrent tumor after locoregional treatment in patients with hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with recurrent hepatocellular carcinoma after locoregional treatment | Experimental | Patients with chronic liver disease have recurrent hepatocellular carcinoma which is diagnosed on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodes | Procedure | Radiofrequency ablation will be performed by using twin cooled-wet electrodes. Two electrodes will be places on the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF, bipolar mode and switching monopolar mode) will be applied to two electrodes at the same time for about 6 to 30 minutes depending on the tumor size. The temperature will be maintained at 90-100 °C. The RF energy will be delivered by using the 200 watts single generator. |
| Measure | Description | Time Frame |
|---|---|---|
| Local tumor progression rate | Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level | 12 months after radiofrequency ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety margin evaluation | Evaluate the safety margin around the index tumor on immediate computed tomography (CT) | Immediately after radiofrequency ablation |
| Technical success rate | Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up computed tomography. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| 1 month after radiofrequency ablation |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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