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Active, Not Recruiting

NCT Number: NCT05666271

Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes

This study is to investigate the therapeutic effect and treatment results of radiofrequency ablation using the Octopus MP electrode capable of temperature monitoring and drug injection and a variable-length electrode for treatment of small hepatocellular carcinomas (≤ 3cm).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

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

  • Child-Pugh Class A or B
  • chronic hepatitis B or chronic hepatitis C or liver cirrhosis
  • presence of hepatocellular carcinoma (HCC) after confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to the Korean Liver Cancer Study Group (KLCSG)-National Cancer Center (NCC) Korea practice guidelines.
  • up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment.

Exclusion criteria

  • number of recurrent HCCs, more than 3
  • largest HCC size over 3 cm
  • presence of vascular invasion by HCC
  • platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
  • presence of extrahepatic metastasis

Treatment and study plan

Radiofrequency ablation

Procedure

Radiofrequency ablation will be performed by using the Octopus MP electrodes. It is a method of directly measuring the temperature near the surrounding tissue of the target tumor using the Octopus MP electrode, and stopping ablation when the temperature rises above 60 degrees to prevent adjacent organ (gallbladder, gastrointestinal tracts, diaphragm, and heart). If the shape of the tumor is elliptical or irregular rather than circular, using an adjustable tip that can change the length of the active tip of the electrode according to the size of the tumor has the advantage of tailoring the ablation zone.

Primary outcomes

  1. Local tumor progression rates

    Time frame: 1 and 2 years after radiofrequency ablation

    local tumor progression (LTP) rates , defined as new tumor foci at the ablation margin after initial complete ablation, as confirmed by a consensus of two radiologists on follow-up imaging

  2. Adjacent organ thermal injury rate

    Time frame: Immediately after radiofrequency ablation

    Evaluate adjacent organ thermal injury rate by immediate follow-up computed tomography after radiofrequency ablation.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus MP Electrodes or Octopus Electrodes With Adjustable Tips: A Prospective Observational Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2022
Registry last updated
Apr 13, 2026

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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