Radiofrequency Ablation Using Cooled-Wet Electrode

Seoul National University

Status: Completed

Conditions: Metastasis; HCC

Treatments: Device: separable clustered electrode; Device: cooled-wet electrode

Study type: Interventional

Funder types: Other

Identifiers

NCT02675894

SNUH-2013-2283

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 77 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups

RFA with cooled-wet electrode

Active Comparator group

Description:

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

Treatment:

Device: cooled-wet electrode

RFA with separable clustered electrode

Active Comparator group

Description:

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

Treatment:

Device: separable clustered electrode