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

NCT ID: NCT06682377

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2025-12-30

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No touch RFA with dual switching monopolar + bipolar mode

Group Type: EXPERIMENTAL

Radiofrequency ablation alone

Intervention Type: PROCEDURE

No touch RFA with dual switching monopolar + bipolar mode

Interventions

Radiofrequency ablation alone

No touch RFA with dual switching monopolar + bipolar mode

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Min Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

2010-068-1163

Identifier Type: -

Identifier Source: org_study_id