Authors' objectives: Strain and shear wave elastography which is commonly used with concurrent real-time imaging known as real-time ultrasound shear/strain wave elastography is a new diagnostic technique that has been reported to be useful in the diagnosis of nodules in several organs. There is conflicting evidence regarding its benefit over ultrasound-guided fine-needle aspiration cytology alone in thyroid nodules. To determine if ultrasound strain and shear wave elastography in conjunction with fine-needle aspiration cytology will reduce the number of patients who have a non-diagnostic first fine-needle aspiration cytology results as compared to conventional ultrasound-only guided fine-needle aspiration cytology. Strain elastography (STE) which is commonly used with concurrent real-time imaging known as real-time elastography (RTE) and shear wave elastography (SWE) are new diagnostic techniques that have been reported to be useful in the diagnosis of nodules in several organs. There is conflicting evidence regarding its benefit over ultrasound-guided fine-needle aspiration cytology (US-FNAC) alone in thyroid nodules. The primary objective was to determine if strain/shear wave ultrasound elastography (USE) in conjunction with FNAC will reduce the number of patients with thyroid nodules who have a non-diagnostic first FNAC result as compared to conventional ultrasound (US)-only guided FNAC.

Authors' results and conclusions: A total of 982 participants (80% female) were randomised: 493 were randomised to ultrasound shear/strain wave elastography-ultrasound guided fine-needle aspiration cytology and 489 were randomised to ultrasound-only guided fine-needle aspiration cytology. There was no evidence of a difference between ultrasound shear/strain wave elastography and ultrasound in non-diagnostic cytology (Thy 1) rate following the first fine-needle aspiration cytology (19% vs. 16% respectively; risk difference: 0.030; 95% confidence interval −0.007 to 0.066; p = 0.11), the number of fine-needle aspiration cytologies needed (odds ratio: 1.10; 95% confidence interval 0.82 to 1.49; p = 0.53) or in the time to reach a definitive diagnosis (hazard ratio: 0.94; 95% confidence interval 0.81 to 1.10; p = 0.45). There was a small, non-significant reduction in the number of thyroid operations undertaken when ultrasound shear/strain wave elastography was used (37% vs. 40% respectively; risk difference: −0.02; 95% confidence interval −0.06 to 0.009; p = 0.15), but no difference in the number of operations yielding benign histology – 23% versus 24% respectively, p = 0.70 (i.e. no increase in identification of malignant cases) – or in the number of serious adverse events (2% vs. 1%). There was no difference in anxiety and depression, pain or quality of life between the two arms. Ultrasound shear/strain wave elastography does not appear to have additional benefit over ultrasound-guided fine-needle aspiration cytology in the diagnosis of thyroid nodules. A total of 982 participants were randomised: 493 were randomised to USE-US guided FNAC and 489 were randomised to US-only guided FNAC. There was no evidence of a difference between USE and US in non-diagnostic (Thy 1) rate following the first FNAC [19% vs. 16% respectively; risk difference (RD): 0.030; 95% confidence interval (CI), −0.007 to 0.066; p = 0.11], the number of FNACs needed [odds ratio (OR): 1.10; 95% CI, 0.82 to 1.49; p = 0.53] or in the time to reach a definitive diagnosis [hazard ratio (HR): 0.94; 95% CI, 0.81 to 1.10; p = 0.45]. There was a small, non-significant reduction in the number of thyroid operations undertaken when USE was used (37% vs. 40% respectively; RD: −0.02; 95% CI, −0.06 to 0.009; p = 0.15), but no difference in the number of operations yielding benign histology – 23% versus 24% respectively, p = 0.70 (i.e. no increase in identification of malignant cases) – or in the number of serious adverse events (2% vs. 1%). There was no difference in anxiety and depression, pain or quality of life between the two arms. Ultrasound shear/strain wave elastography does not appear to have additional benefit over US-FNAC in the diagnosis of thyroid nodules.

Authors' methods: A pragmatic, unblinded, multicentre randomised controlled trial. Eighteen centres with a radiology department across England. Adults who had not undergone previous fine-needle aspiration cytology with single or multiple nodules undergoing investigation. Ultrasound shear/strain wave elastography-ultrasound guided fine-needle aspiration cytology (intervention arm) – strain or shear wave elastography-guided fine-needle aspiration cytology. Ultrasound-only guided fine-needle aspiration cytology (control arm) – routine ultrasound-only guided fine-needle aspiration cytology (the current standard recommended by the British Thyroid Association guidelines). The study was not powered to detect differences in malignancy. ElaTION was a pragmatic, multicentre randomised controlled trial. Eighteen centres with a radiology department across England. Adults with thyroid nodules who had not undergone previous FNAC with single or multiple nodules undergoing investigation. Ultrasound shear/strain wave elastography-US guided FNAC (intervention arm) – strain or shear wave elastography (USE)-guided FNAC. US-only guided FNAC (control arm) – routine US-only guided FNAC (the current standard recommended by the British Thyroid Association guidelines). Primary outcome The proportion of patients who have a non-diagnostic cytology (Thy 1) result following the first FNAC. The study was not powered to detect differences in malignancy.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/12/19/04

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/PLEQ4874

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: United Kingdom

DOI: 10.3310/PLEQ4874

Organisation Name: NIHR Health and Social Care Delivery Program

Contact Name: Rhiannon Miller

Contact Email: rhiannon.m@prepress-projects.co.uk