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

NCT06682377 | Active Not Recruiting DMC

• 1 other identifier: 2010-068-1163
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Estimated local tumor progression rate

  12 months after procedure

Study Arms (1)

No touch RFA with dual switching monopolar + bipolar mode

EXPERIMENTAL

Procedure: Radiofrequency ablation alone

Interventions

Radiofrequency ablation alone PROCEDURE

No touch RFA with dual switching monopolar + bipolar mode

No touch RFA with dual switching monopolar + bipolar mode

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agreement to the protocol requirements and provision of informed consent.
• Age between 20 and 85 years.
• Child-Pugh Class A or B7.
• 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.
• No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years.

You may not qualify if:

• Presence of three or more malignant liver tumors.
• Diffuse infiltrative type tumors with unclear boundaries.
• Recurrent HCC within two years of previous treatment.
• Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm.
• Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance.
• Vascular invasion by malignant liver tumors.
• Severe coagulopathy (platelets \<50,000/mm³ or International Normalized Ratio (INR) \>50% prolongation).
• Presence of extrahepatic metastasis.
• Situations where obtaining appropriate data for the study is unlikely.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 12, 2024
• Study Start: April 5, 2021
• Primary Completion: March 29, 2024
• Study Completion: December 30, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)