Carcinoma, Hepatocellular
Conditions
Keywords
HCC, RFA
Brief summary
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.
Interventions
PROCEDURENo-touch RFA
No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.
PROCEDUREConventional tumor puncture RFA
Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Child-Pugh class A * patient with 1cm-2.5cm sized HCC * 1 or 2 HCCs * being referred for curative purpose of RFA * sign informed consent
Exclusion criteria
* maximum tumor diameter greater than 2.5cm * Child-Pugh class B or C * more than 3 HCC lesions * invisible tumor even after US/CT or US/MR fusion * presence of vascular tumor thrombosis or extrahepatic metastasis * severe coagulopathy (PLT \< 50K, PT \< 50% of normal range)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 month local tumor progression (LTP) rate | 12 month after RFA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tumor seeding rate | 12 months after RFA | incidence of tract seeding after RFA. |
| Complication rate related with RFA | 1 month | RFA-related complication rate such as death, abscess, bleeding..etc. |
| Technical success rate | 1 months | presence or absence of residual lesion on follow-up imaging |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ablation time | 3 days after RFA | ablation time for tumor ablation |
| Technical efficacy 2 | 2 days after RFA | 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 |
| Intrahepatic distant mets | 12 months after RFA | incidence of intrahepatic distant metastasis after RFA |
| Extrahepatic distant mets | 12 months after RFA | incidence of extrahepatic distant metastasis after RFA |
| Technical efficacy 1 | 2 days after RFA | 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 |
Outcome results
None listed