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| Name | Class |
|---|---|
| Starmed | INDUSTRY |
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To evaluate local tumor progression rate at 12 months after percutaneous radiofrequency ablation with gradual radiofrequency energy delivery mode with Octopus electrodes in patients with hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with clinically diagnosed hepatocellular carcinoma (HCC) (equal or less than 4 cm ) | Experimental | Patients with chronic hepatitis B or liver cirrhosis have hepatocellular carcinoma (HCC) (equal or less than 4 cm) 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 gradual radiofrequency energy delivery with Octopus electrodes | Procedure | Radiofrequency ablation (RFA) will be performed by using multi-VIVA generator and Octopus electrodes. Three electrodes will be placed 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) 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. The RF energy will starts at 60 watts and increase by 10 watts every 30 seconds for the first 3 minutes, and then increases gradually by 10 watts per minute after reaching 100 watts. |
| 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 (RFA) |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of cone-unit ablation | The cone-unit ablation is defined as complete ablation of tumor with safety margin and occlusion of the 4th or 5th branches of portal vein. | Immediately after radiofrequency ablation (RFA) |
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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, M.D. | Contact | 82-2-2072-2519 | yyssaa21@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39169297 | Derived | Hwang S, Kim JH, Yu SJ, Lee JM. Incremental high power radiofrequency ablation with multi-electrodes for small hepatocellular carcinoma: a prospective study. BMC Gastroenterol. 2024 Aug 21;24(1):280. doi: 10.1186/s12876-024-03358-w. | |
| 37605251 | Derived | Kim JH, Kim HS, Yoon JH, Joo I, Yoon JH, Kim YJ, Yu SJ, Lee JM. Anatomical ablation for small hepatocellular carcinomas using multiple applicators: a preliminary study. Cancer Imaging. 2023 Aug 21;23(1):78. doi: 10.1186/s40644-023-00597-0. |
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|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008103 | Liver Cirrhosis |
| 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 |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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