Radiofrequency Ablation Using Cooled-Wet Electrode

Not Applicable

Completed

• Conditions: HCC; Metastasis
• Interventions: Device: separable clustered electrode; Device: cooled-wet electrode

• Registration Number: NCT02675894
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-04-14
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-05
• Primary Completion: 2017-01-19
• Study Completion: 2018-04-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA with separable clustered electrode	separable clustered electrode	RFA using separable clustered electrode in switching monopolar mode under the fused US guidance
RFA with cooled-wet electrode	cooled-wet electrode	RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.

Primary Outcome Measures

Name	Time	Method
LTP	24 months	cumulating local tumor progression rate over 2- year after RFA

Secondary Outcome Measures

Name	Time	Method
Technical success rate	1 months	technical success rate on 1 month follow-up which indicates no residual tumor on cross-sectional imaging (CT, MRI)
EM rate	24 months	cumulating extrahepatic metastasis (EM) rate over 2- year after RFA
Complication	12 months	all complication rate and grades (according to Clavien system from I to III) related with RFA procedure
Maximal diameter of ablative zone	7 day	Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.
Volume of ablative zone	7 days	Volume of ablative zone on post-RFA CT or MRI in a mm3.
IDR rate	24 months	cumulating intrahepatic distant recurrence (IDR) rate over 2- year after RFA
ablation time	1 day	RFA procedure time in each patient.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of