High intensity focused ultrasound in the therapy of benign thyroid nodules-first German bicentric study with long-term follow-up

Abstract

Purpose: The study evaluated high-intensity-focused ultrasound (HIFU) for benign thyroid nodules in terms of efficiency, complication rate, influence of preablative nodule size, parameters influencing the therapeutic success and hormonal-thyroid-function.

Methods: Seventy-two patients with 75 nodules were treated with HIFU at 2 centers from 2014-2019. Median nodule volume was 4.4 ml (range 0.33-53). The therapeutic ultrasound probe (EchoPulse THC900888-H) generated 80-90 °C in the target tissue with 87.6-320.3 J per sonication. Nodal volume was measured at baseline and over 12 months after therapy in a retrospective bicentric-study with long-term follow-up. Hormonal-thyroid function (TSH, T3, T4) was measured before and after ablation. Complications were assessed.

Results: Significant volume reduction (p < 0.05 Wilcoxon-signed-rank test) of thyroid nodules was 38.98% at 3 months, 37.32% at 6 months, 61.54% at 9 months and 60.66% at 12 months. Volume reduction of nodules <3 ml did not differ significantly from nodules >3 ml (p > 0.05 Mann-Whitney test). At 3 months solid nodules had a significant volume reduction of 52.08%, complex nodules of 32.57%, nodules treated under regional anesthesia of 33.07% and under general anesthesia of 49.47%. Hormonal-thyroid function was not influenced significantly by HIFU therapy (p > 0.05 Wilcoxon-signed-rank test). Complication rate was 3.8%. No long-term complications occurred.

Conclusion: Significant volume reduction of thyroid nodules up to 12 months after HIFU was shown. All complications were reversible. Therapy was more efficient in solid than complex nodules and in nodules treated under general anesthesia than with regional anesthesia. Hormonal-thyroid-function was not affected.

Trial registraftion number: 2020-1728-evBO. Date of registration: 16.06.2020. Agency: Ethik-Kommission bei der Landesäztekammer Hessen.

Keywords: Benign thyroid nodules; High intensity focused ultrasound; Thermoablative procedure; Volume reduction.