- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05666271
Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes
April 8, 2026 updated by: Jeong Min Lee, Seoul National University Hospital
Radiofrequency Ablation for Small Hepatocellular Carcinoma Using Octopus MP Electrodes or Octopus Electrodes With Adjustable Tips: A Prospective Observational Study
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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Seoul, South Korea
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who have been referred for radiofrequency ablation for the treatment of small hepatocellular carcinomas (equal or less than 3 cm) located in the periphery of the liver (within 5 cm from the liver capsule) on preprocedural computed tomography or magnetic resonance imaging.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adjacent organ thermal injury rate
Time Frame: Immediately after radiofrequency ablation
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Evaluate adjacent organ thermal injury rate by immediate follow-up computed tomography after radiofrequency ablation.
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Immediately after radiofrequency ablation
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Local tumor progression rates
Time Frame: 1 and 2 years after radiofrequency ablation
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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
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1 and 2 years after radiofrequency ablation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2022
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2026
Study Registration Dates
First Submitted
December 18, 2022
First Submitted That Met QC Criteria
December 18, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Therapeutics
- Surgical Procedures, Operative
- Ablation Techniques
- Radiofrequency Therapy
- Radiofrequency Ablation
Other Study ID Numbers
- 2208-116-1351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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