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

Not Applicable

Completed

• Conditions: Metastasis; HCC
• Interventions: Device: DSM; Device: separable clustered electrode

• Registration Number: NCT02675881
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2013-08-05
• Primary Completion: 2015-04-08
• Study Completion: 2015-07-13
• Study First Submitted: 2016-01-31
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RFA DSM	separable clustered electrode	Eligible patients who undergo RFA using DSM and separable clustered electrodes.
RFA DSM	DSM	Eligible patients who undergo RFA using DSM and separable clustered electrodes.

Primary Outcome Measures

Name	Time	Method
local tumor progression (LTP)	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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