Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)

Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).

A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.

Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.

Study Overview

• Status: Completed
• Conditions: HCC; Metastasis
• Intervention / Treatment: Device: DSM; Device: separable clustered electrode

Detailed Description

Increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (RFA).

A combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study.

Based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.

• Study Type: Interventional
• Enrollment (Actual): 60
• 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:

• Hepatocellular carcinoma (according to AASLD guideline or LI-RADS)
• histologically confirmed HCC
• histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer AND
• equal to or larger than 2cm, equal to or smaller than 5cm
• available cross-sectional liver imaging within 30 days before RFA
• signed informed consent

Exclusion Criteria:

• history of local treatment on the index tumor
• more than three tumors in a patient
• tumors in central portion of portal vein or hepatic vein
• Child-Pugh class C
• vascular invasion by tumors
• uncorrected coagulopathy
• presence of multiple extrahepatic metastases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RFA DSM; Eligible patients who undergo RFA using DSM and separable clustered electrodes.	Device: DSM; Monopolar RFA using dual switching mode (DSM); Device: separable clustered electrode; A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.; Other Names: Octopus(R)
No Intervention: RFA SSM; Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
local tumor progression (LTP)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Technical success on 1 months follow-up imaging after RFA (no residual/progressed tumor)	1 months
rate of intrahepatic distant recurrence (IDR) after RFA	12 months
rate of extrahepatic metastasis (EM) after RFA	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal diameter of ablative zone	Maximal diameter of ablative zone on post-RFA CT or MRI in a mm.	7 day
Volume of ablative zone	Volume of ablative zone on post-RFA CT or MRI in a mm3.	7 days
Number of complication of RFA	incidence of any possible complication related with RFA	6 months
ablation time	ablation time in a patient	1 day
Real time US fusion image feasibility	success or failure of accurate fusion between US and pre-RFA cross sectional images	1 day after RFA procedure
Immediate evaluation of ablative zone via visual assess and pre-and post-RFA images registration.	Prediction of LTP by classifying patients according to assessing ablative margin in each method on a four point scale (1: residual tumor, 4: ablative margin equal to or larger than 5mm)	12 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2013
• Primary Completion (Actual): April 8, 2015
• Study Completion (Actual): July 13, 2015

Study Registration Dates

• First Submitted: January 31, 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-2013-1441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES