Chronic Liver Disease, Hepatocellular Carcinoma, Liver Cirrhosis
Conditions
Keywords
Radiofrequency ablation, Gradual radiofrequency energy increment, Cone-unit ablation
Brief summary
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.
Interventions
PROCEDURERadiofrequency ablation using gradual radiofrequency energy delivery with Octopus electrodes
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.
Sponsors
Starmed
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Child-Pugh Class A or B * chronic hepatitis B or liver cirrhosis * contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) within 60 days of scheduled radiofrequency ablation (RFA) date * clinically diagnosed hepatocellular carcinoma (HCC), equal or less than 4 cm
Exclusion criteria
* number of HCC, equal or more than 3 * largest tumor size over 4 cm * Child-Pugh class C * presence of vascular invasion by HCC * platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50% * presence of extrahepatic metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local tumor progression rate | 12 months after radiofrequency ablation (RFA) | Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI) with alpha-fetoprotein (AFP) level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of cone-unit ablation | Immediately after radiofrequency ablation (RFA) | 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. |
Countries
South Korea
Contacts
Primary ContactHyun Hee Lee
Backup ContactJae Hyun Kim, M.D.
Outcome results
None listed