Radiofrequency Ablation Using Cooled-Wet Electrode

Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study

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.

Study Overview

• Status: Completed
• Conditions: HCC; Metastasis
• Intervention / Treatment: Device: cooled-wet electrode; Device: separable clustered electrode

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 Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RFA with cooled-wet electrode; RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.	Device: 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.
Active Comparator: RFA with separable clustered electrode; RFA using separable clustered electrode in switching monopolar mode under the fused US guidance	Device: separable clustered electrode; RFA is performed using separable clustered electrode in switching monopolar mode.; Other Names: Octopus(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LTP	cumulating local tumor progression rate over 2- year after RFA	24 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
US/CT or MR fusion success rate	RFA is performed under real time US guidance and US is fused with pre-RFA CT or MRI before ablation of the index tumor. US/CT or US/MR fusion quality is assessed by an operator.	1 day
Immediate assess of technique success rate	After performing RFA, patients were transferred CT unit to confirm immediate technique success. It is performed in both a) visual inspection using pre-and post-RFA images side-by-side comparison and b) software assisted inspection which register pre-and post-RFA scans. The results would be used to perform additional treatment (2nd look RFA).	2 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: RF medical; Medical Research Collaborating Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2014
• Primary Completion (Actual): January 19, 2017
• Study Completion (Actual): April 24, 2018

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: RFA
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: SNUH-2013-2283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No