Radiofrequency Ablation Using Cooled-Wet Electrode

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

2014-04-14

Study Completion Date

2018-04-24

Brief Summary

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To determine safety, ablative zone, technical success rate and early safety data of recently introduced cool-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors.

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Detailed Description

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To determine safety, ablative zone, technical success rate and early safety data (12 months local tumor progression rate) of recently introduced cooled-wet electrode in eligible patients who are indicative for radiofrequency ablation (RFA) for liver tumors in comparison with currently used separable clustered electrode in our institution. Owing to tissue cooling effect of internally cooled-wet electrode can be used in switching bipolar mode. Patients would be randomized into two groups (cool-wet electrode group and separable clustered electrode in switching monopolar mode). The results from this preliminary study would be used for main study to compare the efficacy and safety data between two electrodes in the future.

Conditions

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HCC Metastasis

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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RFA with cooled-wet electrode

RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.

Group Type ACTIVE_COMPARATOR

cooled-wet electrode

Intervention Type DEVICE

RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.

RFA with separable clustered electrode

RFA using separable clustered electrode in switching monopolar mode under the fused US guidance

Group Type ACTIVE_COMPARATOR

separable clustered electrode

Intervention Type DEVICE

RFA is performed using separable clustered electrode in switching monopolar mode.

Interventions

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cooled-wet electrode

RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.

Intervention Type DEVICE

separable clustered electrode

RFA is performed using separable clustered electrode in switching monopolar mode.

Intervention Type DEVICE

Other Intervention Names

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Octopus(R)

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with HCC (1\~5cm) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
* liver metastasis histologically confirmed or characteristic findings on cross-sectional imaging
* signed informed consent
* treatment naive index tumor (no history of local treatment for an index tumor)

Exclusion Criteria

* more than three tumors in a patients
* tumor size larger than 5cm
* tumor attaches to central portal vein or hepatic vein
* Child-Pugh classification C
* uncorrected coagulopathy
* presence of extrahepatic metastases

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No