Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®) for Treatment of Focal Liver Malignancies: A Preliminary Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- local tumor progression (LTP)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
RFA DSM
Eligible patients who undergo RFA using DSM and separable clustered electrodes.
Intervention: DSM (Device)
RFA DSM
Eligible patients who undergo RFA using DSM and separable clustered electrodes.
Intervention: separable clustered electrode (Device)
RFA SSM
Historical control group consisted of patients underwent RFA in our institution with single switching mode (SSM) and single/ or multiple clustered electrodes.
Outcomes
Primary Outcomes
local tumor progression (LTP)
Time Frame: 12 months
Secondary Outcomes
- rate of extrahepatic metastasis (EM) after RFA(12 months)
- 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)
Investigators
Jeong Min Lee
Professor
Seoul National University Hospital