Evaluation of US Elastography in Thyroid Nodule Diagnosis: The ElaTION Randomized Control Trial

Background There is variable evidence and no randomized trials on the benefit of US elastography-guided fine-needle aspiration cytology (FNAC) over conventional US-guided FNAC alone for thyroid nodules. Purpose To compare the efficacy of US elastography-guided FNAC versus US-guided FNAC in reducing nondiagnostic rates for thyroid nodules. Materials and Methods A pragmatic, multicenter randomized controlled trial was performed at 18 secondary and tertiary hospitals across England between February 2015 and September 2018. Eligible adults with single or multiple thyroid nodules who had not previously undergone FNAC were randomized (1:1 ratio) to US elastography FNAC (intervention) or conventional US FNAC (control). The primary outcome was the proportion of patients who have a nondiagnostic cytologic Thy1 (British Thyroid Association system) result following the first FNAC. Results A total of 982 participants (mean age, 51.3 years ± 15 [SD] [IQR, 39-63]; male-to-female ratio, 1:4) were randomized. Of the 493 participants who underwent US elastography, 467 (94.7%) were examined with strain US elastography. There was no difference between the two arms in the nondiagnostic (Thy1) rate following the first FNAC (19% vs 16%; risk difference [RD], 0.03 [95% CI: -0.01, 0.07];