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NCT Number: NCT06682377

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**Inclusion Criteria**

  • 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.

**Exclusion Criteria**

  • 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.

Treatment and study plan

Radiofrequency ablation alone

Procedure

No touch RFA with dual switching monopolar + bipolar mode

Primary outcomes

  1. Estimated local tumor progression rate

    Time frame: 12 months after procedure

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Evaluation of Clinical Efficacy of Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma: a Prospective Multicenter Study

Acronym: SM-OCT-01

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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