Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666271
• Other study ID #: 2208-116-1351
• Status: Recruiting
• Start date: August 29, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: December 2022
• Source: Seoul National University Hospital
• Contact: Hyun Hee Lee
• Phone: 82-2-2072-4177
• Email: redlion55[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Radiofrequency ablation
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjacent organ thermal injury rate	Evaluate adjacent organ thermal injury rate by immediate follow-up computed tomography after radiofrequency ablation.	Immediately after radiofrequency ablation