Branovan, Daniel Igor1, Drozd, Valentina1,5, Makarov, Igor5, Fridman, Michael2, Schastnaya, Nadezhda3, Filatov, Sergey4, Shiglik, Nikolay1
1 New York Ear, Nose and Throat Institute, United States
2 Republican Centre for Thyroid Tumors, Minsk, Belarus
3 Institute of Physiology, National Academy of Sciences of Belarus
4 A.V. Luikov heat and mass transfer institute of the national academy of sciences of Belarus
5 LTD MedEx-lab, Minsk, Belarus
Background: Traditional surgery may be excessively invasive in some cases of low-risk papillary microcarcinoma, small adenomas and nodular goiter of uncertain malignant potential, particularly in patients averse to surgical intervention. The objective of this study was to evaluate in vivo the efficacy and safety of new low-cost device for bipolar radiofrequency ablation (RFA) «Thyrablator» for treating thyroid lesions.
Method: For preclinical study we are using new originally developed device «Thyrablator» designed as a sterile disposable needle for the fine needle biopsy (20-gauge). Ex vivo preparations of 20 surgically removed thyroid nodules were treated with «Thyrablator» using an Electrosurgical Generator (Integral). During the RFA dynamic temperature control with a thermal imager «IRTIS – 2000?» was performed. The nodules were cut open after the RFA along the thyrablator axis for macroscopically and microscopically inspection.
Results: During the RFA procedure a temperature on the surface of the nodule varied from 25 C° to 89 C°. The temperature started to grow after the fifth second of an application and increased till 20-25 seconds and then began to decrease. The best mode for the RFA procedure can be power 5 W with the time of 10-25 seconds. In the areas of patchy tissue damage (grayish areas from 6 to 13 mm), destructive changes were accompanied by the chief thyroid cells “polarization”, stromal necrobiotic alterations, and spastic/ dilatation reactions of the vessels.
Discussion & Conclusion: Thyrablator is a newly-design device and can effectively eliminate small-sized thyroid nodules. Future investigations should evaluate if the moving-shot technique and/or pre-treatment application will improve efficacy of the RFA.