Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma

NCT ID: NCT06086002

Last Updated: 2023-10-17

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

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-12-31

Brief Summary

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To compare safety and efficacy of microwave ablation with simultaneous ablation using two antennas versus overlapping ablation with single antenna for small hepatocellular carcinoma

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Overlapping ablation with single antenna

Group Type ACTIVE_COMPARATOR

Microwave ablation

Intervention Type DEVICE

Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.

Simultaneous ablation with two antennas

Group Type EXPERIMENTAL

Microwave ablation

Intervention Type DEVICE

Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.

Interventions

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Microwave ablation

Microwave ablation will be performed by using single antenna (Emprint, Medtronic) with overlapping ablation or two antennas (Starwave, STARmed) with simultaneous ablation.

Intervention Type DEVICE

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) confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
* single lesion less than or equal to 3 cm, or 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, equal or more than 3
* largest recurrent HCC size over 3 cm
* presence of vascular invasion by HCC
* diffuse infiltrative type HCC
* HCCs located less than 5 mm from central bile duct or large portal vein or large hepatic vein
* 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

82-2-2072-4177

Jae Hyun Kim

Role: CONTACT

82-2-2072-2519

Facility Contacts

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Hyun Hee Lee

Role: primary

82-2-2072-4177

Other Identifiers

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2308-023-1457

Identifier Type: -

Identifier Source: org_study_id

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