Chronic Liver Disease and Cirrhosis, Recurrent Hepatocellular Cancer
Conditions
Keywords
No-touch radiofrequency ablation, Combined energy delivery mode, Triple cooled-wet electrodes
Brief summary
To evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes
Interventions
PROCEDURERadiofrequency ablation using combined bipolar and monopolar energy deliver with Triple Cooled-Wet electrodes
Radiofrequency ablation will be performed by using triple cooled-wet electrodes. Two or three electrodes will be places around the tumor under ultrasonography (US)-computed tomography (CT)/magnetic resonance (MR) fusion tool guidance. The electrodes will be cooled with saline, and radiofrequency (RF, bipolar mode and switching monopolar mode) 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.
Sponsors
RF medical
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 chronic hepatitis C or liver cirrhosis * presence of recurrent hepatocellular carcinoma (HCC) after locoregional treatment confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018 * single lesion less than or equal to 5 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment
Exclusion criteria
* number of recurrent HCCs, equal or more than 3 * largest recurrent HCC size over 3 cm * 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 | 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 |
|---|---|---|
| Disease-free survival | 12 moths after radiofrequency ablation | Evaluate disease-free survival by available clinical information and follow-up computed tomography or magnetic resonance imaging with alpha-fetoprotein level |
| Technical success rate | 1 month after radiofrequency ablation | Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 3 mm on 1 month follow-up CT. |
| Overall survival | 12 moths after radiofrequency ablation | Evaluate overall survival by available clinical information and follow-up |
| Complication rate | 1, 3, 6, 9, 12 months after radiofrequency ablation. | Evaluate the presence of major or minor radiofrequency ablation related complications on follow-up computed tomography or magnetic resonance imaging. |
Countries
South Korea
Contacts
Primary ContactHyun Hee Lee
Backup ContactJae Hyun Kim
Outcome results
None listed