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In this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of Radiofrequency ablation (RFA) with octopus electrode and no-touch technique for Hepatocellular carcinoma (HCC) to those of RFA with conventional tumor puncture method with the same device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-touch RFA arm | Experimental | No-touch RFA arm indicates RFA procedure using Octopus electrode and no touch technique. |
|
| Conventional tumor puncture RFA arm | Active Comparator | Conventional tumor puncture RFA arm indicates RFA procedure using Octopus electrode and conventional tumor puncture technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No-touch RFA | Procedure | No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12 month local tumor progression (LTP) rate | 12 month after RFA |
| Measure | Description | Time Frame |
|---|---|---|
| tumor seeding rate | incidence of tract seeding after RFA. | 12 months after RFA |
| Complication rate related with RFA | RFA-related complication rate such as death, abscess, bleeding..etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Ablation time | ablation time for tumor ablation | 3 days after RFA |
| Intrahepatic distant mets | incidence of intrahepatic distant metastasis after RFA |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
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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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| Conventional tumor puncture RFA | Procedure | Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes. |
|
| 1 month |
| Technical success rate | presence or absence of residual lesion on follow-up imaging | 1 months |
| 12 months after RFA |
| Extrahepatic distant mets | incidence of extrahepatic distant metastasis after RFA | 12 months after RFA |
| Technical efficacy 1 | Assessment of ablative margin using score 1-4 (1: residual tumor; 4: equal to or larger than 5mm) in side-by-side comparison of pre-RFA CT/MR and post-RFA CT using visual assessment | 2 days after RFA |
| Technical efficacy 2 | Assessment of ablative margin using score 1-4 (1: residual tumor; 4: equal to or larger than 5mm) in side-by-side comparison of pre-RFA CT/MR and post-RFA CT using registration software | 2 days after RFA |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |