Carcinoma, Hepatocellular
Conditions
Keywords
HCC, RFA
Brief summary
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.
Interventions
PROCEDURENo-touch RFA arm
No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
PROCEDUREConventional tumor puncture RFA arm
Conventional tumor puncture RFA arm indicates RFA procedure using conventional tumor puncture technique. In this study, RFA is done by using dual cooled electrode.
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 1-2.5cm sized HCC * 1 or 2 HCC lesions
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 months after RFA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2. tumor seeding rate | 12 months after RFA | — |
| Complication rate related with RFA | 1 month after RFA | RFA-related complication rate such as death, abscess, bleeding..etc. |
| Technical success rate | 1 month after RFA | 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 |
Countries
South Korea
Contacts
Primary ContactHyun Hee Lee, RN
Outcome results
None listed