Ireland
--:--IST
Active, not recruiting Not applicable

Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma

NCT06682377 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2021-04-05
Last updated
2024-11-12

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

Radiofrequency ablation alone

Radiofrequency ablation alone: No touch RFA with dual switching monopolar + bipolar mode

Study summary

The purpose of this study is to evaluate, through a prospective multicenter trial, the procedural time, safety, technical success rate for achieving a safety margin of at least 5 mm around the tumor, and the clinical efficacy (local and remote recurrence rates: estimated local recurrence rate at 12 months) of radiofrequency ablation using the "No-touch" technique. This approach employs Octopus electrodes and combined radiofrequency energy delivery (dual switching monopolar and bipolar mode) for the treatment of hepatocellular carcinoma.

Eligibility

Sex
ALL
Min age
20 Years
Max age
85 Years
Healthy volunteers
No
\*\*Inclusion Criteria\*\* 1. Agreement to the protocol requirements and provision of informed consent. 2. Age between 20 and 85 years. 3. Child-Pugh Class A or B7. 4. Patients with liver cirrhosis who are candidates for radiofrequency ablation (RFA) based on multi-detector computed tomography (MDCT) or multi-detector computed tomography (MRI) within 60 days, with a suspected hepatocellular carcinoma (HCC) lesion of 1-3 cm. * \*\*HCC Diagnostic Criteria:\*\* A. Presence of risk factors (e.g., hepatitis B virus (HBV) positive, hepatitis C virus (HCV) positive, liver cirrhosis). B. Findings consistent with HCC on at least one imaging modality (MDCT, dynamic MRI, or Primovist MRI) according to the Korean Liver Cancer Association (KLCA) criteria. C. Histological diagnosis of HCC. 5. No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years. \*\*Exclusion Criteria\*\* 1. Presence of three or more malignant liver tumors. 2. Diffuse infiltrative type tumors with unclear boundaries. 3. Recurrent HCC within two years of previous treatment. 4. Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm. 5. Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance. 6. Vascular invasion by malignant liver tumors. 7. Severe coagulopathy (platelets \<50,000/mm³ or International Normalized Ratio (INR) \>50% prolongation). 8. Presence of extrahepatic metastasis. 9. Situations where obtaining appropriate data for the study is unlikely.

Primary outcome measure(s)

  • Estimated local tumor progression rate — 12 months after procedure

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Seoul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06682377 on ClinicalTrials.gov ↗ ← All trials in South Korea