Effects of Ultrasound-Guided Laser Ablation Therapy on Symptomatic Benign Thyroid Nodules, Using EchoLaser - Results of a Pilot Study in the United States

Abstract

Objective: To evalate the efficacy of single ultrasound-guided laser ablation treatment on symptomatic benign thyroid nodules in outpatient setting, we conducted a single-center, prospective, nonrandomized, open label interventional study.

Methods: This study included adults with normal thyroid function and symptomatic thyroid nodules measuring >29 mm and ≤60 mm with <20% cystic area by ultrasound. Laser ablation energy was calculated based on device guidelines. A single nodule was treated under local anesthesia. Each application session lasted between 400 and 600 seconds under a laser power output of 3 W.

Results: Ten subjects underwent the procedure and 9 subjects completed 12-month follow-up. Baseline thyroid nodule volumes ranged from 5.51 to 28.22 mL and the total energy delivered ranged from 1477.00 to 7206.50 J. The average nodule volume reduction at 12 months after procedure for 9 patients was 71.087%. Nodules were visible from >1 m away at baseline for all 10 subjects and not visible in 8 of 10 at 3 months and 6 of 9 subjects at 12 months. Most subjects reported that they would likely undergo the procedure again. No significant adverse events were reported.

Conclusion: This study demonstrated the feasibility of performing laser ablation in a clinical setting in the United States. Reduction in nodule volume and symptoms were observed, and the procedure was tolerated well by the subjects.

Keywords: laser ablation; minimally invasive; thyroid nodule.