Bipolar RFA Using Twin ICW Electrodes vs. Switching Monopolar RFA for Recurrent HCC

NCT ID: NCT03806218

Last Updated: 2020-04-07

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

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-16

Study Completion Date

2019-02-12

Brief Summary

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This study was conducted to provide preliminary data for the main trial to compare efficacy between bipolar radiofrequency ablation (RFA) using twin internally cooled-wet electrodes and switching monopolar RFA using separable clustered electrodes in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.

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

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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TICW-RFA

Bipolar RFA using twin internally cooled-wet electrodes

Group Type ACTIVE_COMPARATOR

Bipolar RFA

Intervention Type DEVICE

Bipolar RFA in which RF currents flow between two electrodes

Twin internally cooled-wet electrodes

Intervention Type DEVICE

Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity

SC-RFA

Switching monopolar RFA using separable clustered electrodes

Group Type ACTIVE_COMPARATOR

SM-RFA

Intervention Type DEVICE

Monopolar RFA using multiple electrodes with switching mode

Separable clustered electrodes

Intervention Type DEVICE

A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.

Interventions

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Bipolar RFA

Bipolar RFA in which RF currents flow between two electrodes

Intervention Type DEVICE

SM-RFA

Monopolar RFA using multiple electrodes with switching mode

Intervention Type DEVICE

Twin internally cooled-wet electrodes

Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity

Intervention Type DEVICE

Separable clustered electrodes

A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.

Intervention Type DEVICE

Other Intervention Names

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CWTN-T Octopus®

Eligibility Criteria

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Inclusion Criteria

* radiologic or pathologic diagnosis of HCC recurrence after locoregional treatment
* HCC nodules measuring 1 cm or larger and smaller than 5 cm

Exclusion Criteria

* more than three HCC nodules
* tumors with major vascular invasion or abutment to the central portal or hepatic vein with a diameter \> 5mm
* extrahepatic metastasis
* Child-Pugh class C
* severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or prothrombin time international normalized ratio (PT-INR) prolongation of more than 50 %)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 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

Countries

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South Korea

References

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Choi JW, Lee JM, Lee DH, Yoon JH, Kim YJ, Lee JH, Yu SJ, Cho EJ. Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study. PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.

Reference Type DERIVED
PMID: 32986758 (View on PubMed)

Other Identifiers

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SNUH-2015-0401

Identifier Type: -

Identifier Source: org_study_id

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