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| Name | Class |
|---|---|
| RF medical | UNKNOWN |
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To evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes
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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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes | Procedure | Radiofrequency ablation will be performed by using triple cooled-wet electrodes. Two or three electrodes will be places around 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 of three 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. |
| 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 |
|---|---|---|
| Disease-free survival | Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level | 12 moths after radiofrequency ablation |
| Technical success rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Hee Lee | Contact | 82-2-2072-4177 | redlion55@naver.com | |
| Jae Hyun Kim | Contact | 82-2-2072-2519 | yyssaa21@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 3 mm on 1 month follow-up CT.
| 1 month after radiofrequency ablation |
| Overall survival | Evaluate overall survival by available clinical information and follow-up | 12 moths after radiofrequency ablation |
| Complication rate | Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging. | 1, 3, 6, 9, 12 months after radiofrequency ablation. |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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