Hepatocellular Carcinoma, Local Recurrence of Malignant Tumor of Liver
Conditions
Brief summary
To investigate the therapeutic effects and treatment results of radiofrequency ablation using combined bipolar and monopolar energy deliver with twin cooled-wet electrodes for recurrent tumor after locoregional treatment in patients with hepatocellular carcinoma.
Interventions
PROCEDURERadiofrequency ablation using combined bipolar and monopolar energy deliver with Twin Cooled-Wet electrodes
Radiofrequency ablation will be performed by using twin cooled-wet electrodes. Two electrodes will be places 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, bipolar mode and switching monopolar mode) will be applied to two 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 be delivered by using the 200 watts single generator.
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 |
|---|---|---|
| Safety margin evaluation | Immediately after radiofrequency ablation | Evaluate the safety margin around the index tumor on immediate computed tomography (CT) |
| Technical success rate | 1 month after radiofrequency ablation | Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up computed tomography. |
Countries
South Korea
Outcome results
None listed