RFA for Small HCC With No-touch Technique and Dual Cooled-Wet Electrode

NCT ID: NCT02806076

Last Updated: 2021-03-19

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2024-03-30

Brief Summary

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The purpose of this study is to prospectively compare the clinical outcomes (local tumor progression rate, technical success rate, complication rate) of no touch radiofrequency ablation (RFA) technique for Hepatocellular carcinoma (HCC) to those of conventional tumor puncture RFA technique.

Detailed Description

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Conditions

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Carcinoma, Hepatocellular

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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No-touch RFA arm

No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.

Group Type EXPERIMENTAL

No-touch RFA arm

Intervention Type PROCEDURE

No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.

Conventional tumor puncture RFA arm

Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.

Group Type ACTIVE_COMPARATOR

Conventional tumor puncture RFA arm

Intervention Type PROCEDURE

Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.

Interventions

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No-touch RFA arm

No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.

Intervention Type PROCEDURE

Conventional tumor puncture RFA arm

Conventional tumor puncture RFA arm indicates RFA procedure using "conventional tumor puncture" technique. In this study, RFA is done by using dual cooled electrode.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Child-Pugh class A
* patient with 1-2.5cm sized HCC
* 1 or 2 HCC lesions

Exclusion Criteria

* maximum tumor diameter greater than 2.5cm
* Child-Pugh class B or C
* more than 3 HCC lesions
* invisible tumor even after US/CT or US/MR fusion
* presence of vascular tumor thrombosis or extrahepatic metastasis
* severe coagulopathy (PLT \< 50K, PT \< 50% of normal range)
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

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

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, RN

Role: CONTACT

82-2-2072-4177

Other Identifiers

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SNUH-2016-2243

Identifier Type: -

Identifier Source: org_study_id

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