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Radiofrequency Ablation Using Cooled-Wet Electrode

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Hcc

Disease Information

Hcc
Descriptive Information
Brief Title † Radiofrequency Ablation Using Cooled-Wet Electrode
Official Title † Switching Bipolar Radiofrequency Ablation Using Cooled-Wet Electrode for Treatment of Hepatocellular Carcinoma: A Preliminary Study
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 Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † LTP
Secondary Outcome Measure † Technical success rate
Condition † HCC Metastasis
Intervention † Devicecooled-wet electrode
Study Arms / Comparison Groups RFA with cooled-wet electrode RFA is performed using three cool-wet electrodes in switching bipolar mode under the fused US guidance. RFA with separable clustered electrode RFA using separable clustered electrode in switching monopolar mode under the fused US guidance
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 77
Start Date † November 2013
Completion Date February 2018
Primary Completion Date January 2016
Eligibility Criteria † 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
Gender All
Ages 20 Years - 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Korea, Republic of
Administrative Information
NCT ID † NCT02675894
Organization ID SNUH-2013-2283
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Seoul National University Hospital
Collaborators †† RF medical
Investigators † Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital
Information Provided By
Verification Date April 2017
First Received Date † February 1, 2016
Last Updated Date April 4, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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