Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma (SM-OCT-01)

Seoul National University

Status: Active, not recruiting

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Procedure: Radiofrequency ablation alone

Study type: Interventional

Funder types: Other

Identifiers

NCT06682377

2010-068-1163

Details and patient eligibility

About

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.

Enrollment: 159 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

**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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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159 participants in 1 patient group

No touch RFA with dual switching monopolar + bipolar mode

Experimental group

Treatment:

Procedure: Radiofrequency ablation alone