Diagnostic performance of ultrasound vs. ultrasound-guided FNAc in thyroid nodules: data from the ElaTION trial.

Autor:	Mehanna H; Institute of Head and Neck Studies and Education (InHANSE), Institute of Cancer and Genomic Sciences, University of Birmingham, Robert Aitken Building, 2nd Floor, Birmingham, B15 2TT, UK., Nankivell P; Institute of Head and Neck Studies and Education, Institute of Cancer and Genomic Sciences, University of Birmingham, Robert Aitken Building, 2nd Floor, Birmingham, B15 2TT, UK., Boelaert K; Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT., Woolley R; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK., Sharma N; Department of Otolaryngology, Head and Neck Surgery, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham, B15 2TH, UK., Sidhu PS; Department of Imaging Sciences, School of Biomedical Engineering and Imaging Sciences, King's College London, London, SE17EH, UK; Department of Radiology, King's College Hospital NHS Foundation Trust, Denmark Hill, London, SE5 9RS, UK., Madani G; Imaging Department, Imperial College Healthcare NHS Trust, St Mary's Hospital, Praed Street, London W2 INY., Da Forno P; Dept of Pathology, University Hospitals Leicester, Leicester, UK., Moreman C; Dept of Pathology, University Hospitals Leicester, Leicester, UK., Palmer A; Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK., Fulton-Lieuw T; Institute of Head and Neck Studies and Education (InHANSE), University of Birmingham, Robert Aitken Building, 2nd Floor, Birmingham, B15 2TT, UK., Taylor J; Patient Representative, c/o Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK., Rajaguru K; Radiology Department, Lister Hospital, Stevenage, SG1 4AB, UK., Bekker J; Consultant H&N Radiologist, Portsmouth Hospitals University NHS Trust, PO6 3LY, UK., Vaidhyanath R; Department of Radiology, Leicester Royal Infirmary, Leicester, LE1 5WW, UK., Rehman T; Mid and South Essex NHS Foundation Trust, Basildon University Hospital, Nether Mayne, Basildon, Essex, SS16 5NL, UK., Deeks J; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.
Jazyk:	angličtina
Zdroj:	The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2024 Oct 03. Date of Electronic Publication: 2024 Oct 03.
DOI:	10.1210/clinem/dgae682
Abstrakt:	Introduction: ElaTION is a large multi-centre pragmatic randomised controlled trial, performed in 18 secondary/tertiary hospitals across England, comparing elastography ultrasound-guided fine needle aspiration cytology (EUS-FNAC) with ultrasound-guided FNAC (US-FNAC) alone in the diagnostic assessment of thyroid nodules. Secondary trial outcomes, reported here, assessed the accuracy of ultrasound-alone (US) compared with US-guided FNAC to inform and update current practice guidelines. Methods: Adults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) versus US-FNAC. Results: Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses. The sensitivity of US-alone was the same as US-FNAC (0.91, [95% CI 0.85, 0.97] vs 0.87 [95%CI 0.80-0.95], p=0.37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, p<0.0001). The malignancy rate on histology in a nodule classified as benign on ultrasound (U2) was 9/263 (3.42%) and on cytology (Thy2) was 15/353 (4.25%), whereas the malignancy rate in a nodule that was benign on both (U2, Thy2) was 3/210 (1.43%). Malignancy risk for U3, U4, and U5 nodules was 68/304 (22.4%), 43/83 (51.8%), and 29/38 (76.3%) respectively (p<0.0001). Yet 80/982 (8%) patients were discharged despite having U3-U5 scans with Thy1 (non-diagnostic) FNAC and no definitive diagnosis.Malignancy risk was higher in smaller nodules: <10mm 23/60 (38.3%), 10-20mm 46/162 (28.4 %), and >20mm 80/466 (17.2%) (p<0.0001). Nodules with indeterminate cytology with atypical features (Thy3a) carried a similar malignancy risk to those with indeterminate cytology (Thy3/3f): 27/95 (28.4%) versus 42/113 (37.2%) respectively (p=0.18). Conclusion: Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the BTA classification. However, findings also suggest caution regarding existing recommendations for conservative management of non-diagnostic (Thy1/Bethesda I) and atypical (Thy3a/Bethesda III) nodules. In those cases, ultrasound (U3-5) features may help identify high-risk subgroups for more proactive management. (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu