Overview

This trial is active, not recruiting.

Conditions hcc, metastasis
Treatments cooled-wet electrode, separable clustered electrode
Sponsor Seoul National University Hospital
Collaborator RF medical
Start date November 2013
End date January 2016
Trial size 77 participants
Trial identifier NCT02675894, SNUH-2013-2283

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance.
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 using separable clustered electrode in switching monopolar mode under the fused US guidance
separable clustered electrode Octopus(R)
RFA is performed using separable clustered electrode in switching monopolar mode.

Primary Outcomes

Measure
LTP over 1 year rate
time frame: 12 months

Secondary Outcomes

Measure
Technical success rate
time frame: 1 months
IDR rate
time frame: 12 months
EM rate
time frame: 12 months
Maximal diameter of ablative zone
time frame: 7 day
ablation time
time frame: 1 day
Complication
time frame: 12 months
Volume of ablative zone
time frame: 7 days

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

Official title Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
Principal investigator Jeong Min Lee, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.