Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- LTP
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
RFA with cooled-wet electrode
RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.
Intervention: cooled-wet electrode (Device)
RFA with separable clustered electrode
RFA using separable clustered electrode in switching monopolar mode under the fused US guidance
Intervention: separable clustered electrode (Device)
Outcomes
Primary Outcomes
LTP
Time Frame: 24 months
cumulating local tumor progression rate over 2- year after RFA
Secondary Outcomes
- EM rate(24 months)
- Technical success rate(1 months)
- Complication(12 months)
- Maximal diameter of ablative zone(7 day)
- Volume of ablative zone(7 days)
- IDR rate(24 months)
- ablation time(1 day)
Investigators
Jeong Min Lee
Professor
Seoul National University Hospital