Trial reportHealth technology assessment (Winchester, England)2024
Real-time ultrasound elastography in the diagnosis of newly identified thyroid nodules in adults: the ElaTION RCT.
Trial report in Health technology assessment (Winchester, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Shear wave elastography combined with fine-needle aspiration biopsy in the diagnosis of China Thyroid Imaging Reporting and Data System category 4 thyroid nodules.Gland surgery · 2026Article
- The Value of a Predictive Model Based on Multimodal Ultrasound Imaging Biomarkers Combined with Clinical Features in the Diagnosis of Thyroid Nodules.Current medical imaging · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: 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. Objectives: 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. Design: A pragmatic, unblinded, multicentre randomised controlled trial. Setting: Eighteen centres with a radiology department across England. Participants: Adults who had not undergone previous fine-needle aspiration cytology with single or multiple nodules undergoing investigation. Interventions: 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). Main outcome measure: The proportion of patients who have a non-diagnostic cytology (Thy 1) result following the first fine-needle aspiration cytology. Randomisation: Patients were randomised at a 1 : 1 ratio to the interventional or control arms. Results: 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; Limitations: The study was not powered to detect differences in malignancy. Conclusions: 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. Future work: The findings of the ElaTION trial suggest that further research into the use of shear wave elastography in the diagnostic setting of thyroid nodules is unlikely to be warranted unless there are improvements in the technology. The diagnostic difficulty in distinguishing between benign and malignant lesions still persists. Future studies might examine the role of genomic testing on fine-needle aspiration samples. There is growing use of targeted panels of molecular markers, particularly aimed at improving the diagnostic accuracy of indeterminate (i.e. Thy3) cytology results. The application of these tests is not uniform, and their cost effectiveness has not been assessed in large-scale trials. Study registration: This study is registered as ISRCTN (ISRCTN18261857). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/19/04) and is published in full in
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