Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes

NCT05666271 | Active Not Recruiting

• 1 other identifier: 2208-116-1351
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Local tumor progression rates

  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

  1 and 2 years after radiofrequency ablation

• Adjacent organ thermal injury rate

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

  Immediately after radiofrequency ablation

Interventions

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.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: December 27, 2022
• Study Start: August 29, 2022
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)