Radiofrequency Ablation for Hepatocellular Carcinoma Using Octopus MP Electrodes

NCT ID: NCT05666271

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-29

Study Completion Date

2024-08-30

Brief Summary

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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).

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun Hee Lee

Role: CONTACT

Phone: 82-2-2072-4177

Email: [email protected]

Jae Hyun Kim, M.D.

Role: CONTACT

Phone: 82-2-2072-2519

Email: [email protected]

Facility Contacts

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Hyun Hee Lee

Role: primary

Other Identifiers

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2208-116-1351

Identifier Type: -

Identifier Source: org_study_id