Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules.

Cesareo, Roberto; Pasqualini, Valerio; Simeoni, Carla; Sacchi, Marco; Saralli, Erminio; Campagna, Giuseppe; Cianni, Roberto

CONTEXT Ultrasound-guided radiofrequency ablation (RFA) of solid thyroid nodules (TNs) is a minimally invasive procedure that may induce a volume reduction of symptomatic solid benign TNs. OBJECTIVE The aim of the study was to evaluate the effectiveness and safety of RFA in debulking benign TNs. DESIGN AND PATIENTS Eighty-four consecutive patients with symptomatic and cytologically benign solid nodules were randomly assigned to either a single RFA session (group A; n = 42) or follow-up (group B; n = 42) at our center. Entry criteria were a solid thyroid nodule or predominantly solid (with a fluid component ≤ 30% of the volume), normal thyroid function, no autoimmunity, and no previous thyroid gland treatment. Three subgroups were formed according to the baseline volume of nodules: small (≤ 12 mL), medium (from 12 to 30 mL), or large (>30 mL). METHODS In group A RFA was performed in a single session with the moving-shot technique. Volume and local symptom changes were evaluated 1 and 6 months after RFA. RESULTS In group A, the volume decreased from 24.5.5 ± 19.6 to 8.6 ± 9.5 6 months after RFA (P = .001). The greatest volume reduction was in small nodules. The pressure symptom score improved only in medium and large nodules (P < .001), whereas the cosmetic score improved in all treated patients (P < .001). The rate of thyroid volumetric reduction was not statistically different between solid and predominantly solid nodules. Only one patient experienced permanent right paramedian vocal cord palsy with inspiratory stridor without dysphonia. In group B, nodule volume remained unchanged, whereas the symptom score was worse at the 6-month evaluation (P = .01). CONCLUSIONS RFA is effective in reducing thyroid nodule volume. The best reduction rate was observed in small TNs. The thyroid volumetric reduction does not change according to the sonographic features. The mean treatment duration was longer in larger TNs.