Efficacy and Safety of Radiofrequency Ablation versus Control Condition for Nonfunctioning Benign Thyroid Nodules: A Randomized Controlled International Collaborative Trial.

Background: Percutaneous radiofrequency thermal ablation (RFA) has been reported as an effective tool for the management of benign thyroid nodules (BTN). However, large, randomized controlled trials (RCTs) are lacking. Objective: The aims of this study were to assess the volume reduction of BTN after a single RFA performed using the moving-shot technique and to compare the volume reduction obtained in patients treated in two centers with different experience of the moving-shot technique. Method: This study was an international prospective RCT. It was carried out at the Mauriziano Hospital (Turin, Italy) and the Asan Medical Center (Seoul, Korea). Eighty patients harboring solid, compressive, nonfunctioning BTN (volume 10-20 mL) were enrolled. Twenty patients in each country were treated by RFA using a 18-Gauge internally cooled electrode (group A); 20 nontreated patients in each country were followed as controls (group B). Results: At six months, BTN volume significantly decreased in group A (15.1 +/- 3.1 mL vs. 4.2 +/- 2.7 mL; p<0.0001), whereas it remained unchanged in group B (14.4 +/- 3.3 mL vs. 15.2 +/- 3.5 mL). The baseline volume was larger in the Italian series (16.4 +/- 2.5 mL vs. 13.9 +/- 3.3 mL, p=0.009). However, at six months, there was no significant difference between the Korean group and the Italian group (3.7 +/- 2.9 mL vs. 5.5 +/- 2.2 mL). Both cosmetic and compressive symptoms significantly improved (3.6 +/- 0.5 vs. 1.7 +/- 0.4 and 3.6 +/- 1.9 vs. 0.4 +/- 0.7, respectively; p<0.001). No side effects occurred. Conclusions: RFA was effective in reducing the volume of BTN. The outcome was similar in centers with different experience in the moving-shot technique.