Radiofrequency Ablation Using Cooled-Wet Electrode

Seoul National University Hospital77 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

HCC Metastasis

Interventions

cooled-wet electrodeDEVICE

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.

separable clustered electrodeDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: all conditions have to be fulfilled. * 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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

LTP

cumulating local tumor progression rate over 2- year after RFA

Time frame: 24 months

Secondary Outcomes

Technical success rate

technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI)

Time frame: 1 months

IDR rate

cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA

Time frame: 24 months

EM rate

cumulating extrahepatic metastasis (EM) rate over 2- year after RFA

Time frame: 24 months

Maximal diameter of ablative zone

Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.

Time frame: 7 day

ablation time

RFA procedure time in each patient.

Time frame: 1 day

Complication

all complication rate and grades (according to Clavien system from I to III) related with RFA procedure

Time frame: 12 months

Volume of ablative zone

Volume of ablative zone on post-RFA CT or MRI in a mm3.

Time frame: 7 days

Data from ClinicalTrials.gov

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