Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-touch RFA arm | Experimental | No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode. |
|
| Conventional tumor puncture RFA arm | Active Comparator | Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No-touch RFA arm | Procedure | No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12 month local tumor progression (LTP) rate | 12 months after RFA |
| Measure | Description | Time Frame |
|---|---|---|
| 2. tumor seeding rate | 12 months after RFA | |
| Complication rate related with RFA | RFA-related complication rate such as death, abscess, bleeding..etc. | 1 month after RFA |
| 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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Hee Lee, RN | Contact | 82-2-2072-4177 | redlion55@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional tumor puncture RFA arm | Procedure | Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode. |
|
| Technical success rate | presence or absence of residual lesion on follow-up imaging | 1 month after RFA |
| 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 |