Clinical Study of a Novel Coaxial Bipolar Tool (Thyrablator) for Treatment of Thyroid Nodules

  • Recently Bipolar Radiofrequency ablation (BRFA) has been widely used to treat thyroid nodules, and its effectiveness and safety must be proven.

    Methods:  For clinical trial we are using new originally developed device for BRFA – «Thyrablator» – designed as a sterile disposable needle for the fine needle biopsy (20-gauge).
    During the period from January 2017 to October 2018 two sets of patients with benign thyroid nodules were involved in clinical study. Protocol of clinical trial was officially approved.
    Ultrasound (US) – guided percutaneous BRFA was carried out in a first set of 24 patients. BRFA was performed with series of up to 5 pulses with the power of 3 to 5 Watt and duration of 30-60 seconds with EMED-Spectrum electrosurgical unit (Poland). A 30- and 60- day follow up out-patient visits were planned.

    Second set of 22 patients underwent thyroid surgery and BRFA was used at the stage of surgical separation of the organ from the surrounding tissues. The morphological study of surgically removed nodules was done.

    Results: After surgery on gross examination the coagulated lesions were sharply demarcated against the visually unchanged thyroid tissue, sized up to 3-12 mm in diameter. After ultrasound-guided percutaneous BRFA mean residual volume of the nodules during the 30 days follow up (comparing to initial) was 63,38±3,95%, after 60 days – 54,19±7,12%. No post-procedure complications were detected.

    Conclusions: Our results show effectiveness and safety of “Thyrablator” during ultrasound-guided percutaneous BRFA and could be suitable for the treatment of small thyroid nodules during thyroid organ preserving surgery.

 

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