Hepatocellular Carcinoma
Conditions
Brief summary
This study is to investigate the therapeutic effect and treatment results of radiofrequency ablation using the Octopus MP electrode capable of temperature monitoring and drug injection and a variable-length electrode for treatment of small hepatocellular carcinomas (≤ 3cm).
Interventions
PROCEDURERadiofrequency ablation
Radiofrequency ablation will be performed by using the Octopus MP electrodes. It is a method of directly measuring the temperature near the surrounding tissue of the target tumor using the Octopus MP electrode, and stopping ablation when the temperature rises above 60 degrees to prevent adjacent organ (gallbladder, gastrointestinal tracts, diaphragm, and heart). If the shape of the tumor is elliptical or irregular rather than circular, using an adjustable tip that can change the length of the active tip of the electrode according to the size of the tumor has the advantage of tailoring the ablation zone.
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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 hepatocellular carcinoma (HCC) after confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to the Korean Liver Cancer Study Group (KLCSG)-National Cancer Center (NCC) Korea practice guidelines. * 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, more than 3 * largest 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 rates | 1 and 2 years after radiofrequency ablation | local tumor progression (LTP) rates , defined as new tumor foci at the ablation margin after initial complete ablation, as confirmed by a consensus of two radiologists on follow-up imaging |
| Adjacent organ thermal injury rate | Immediately after radiofrequency ablation | Evaluate adjacent organ thermal injury rate by immediate follow-up computed tomography after radiofrequency ablation. |
Countries
South Korea
Outcome results
None listed