Evidence map›Paper›PMID 39359050›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2025

Diagnostic Performance of Ultrasound vs Ultrasound-Guided FNAC in Thyroid Nodules: Data From the ElaTION Trial.

Hisham Mehanna, Paul Nankivell, Kristien Boelaert, Rebecca Woolley, Neil Sharma, Paul S Sidhu, Gitta Madani, Philip Da Forno, Catherine Moreman, Andrew Palmer and 7 more

Abstract readMulticenter StudyRandomized Controlled TrialComparative Study
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Hisham MehannaInstitute of Head and Neck Studies and Education (InHANSE), Department of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK.ORCID 0000-0002-5544-6224
Paul NankivellInstitute of Head and Neck Studies and Education (InHANSE), Department of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK.ORCID 0000-0003-4664-6117
Kristien BoelaertInstitute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.ORCID 0000-0002-6435-177X
Rebecca WoolleyBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.ORCID 0000-0001-5119-1431
Neil SharmaDepartment of Otolaryngology, Head and Neck Surgery, Queen Elizabeth Hospital Birmingham, Birmingham, B15 2TH, UK.ORCID 0000-0001-6776-0977
Paul S SidhuDepartment of Imaging Sciences, School of Biomedical Engineering and Imaging Sciences, King's College London, London, SE17EH, UK.ORCID 0000-0003-1928-4077
Gitta MadaniImaging Department, Imperial College Healthcare NHS Trust, St Mary's Hospital, London, W2 INY, UK.
Philip Da FornoDepartment of Pathology, University Hospitals Leicester, Leicester, LE1 5WW, UK.
Catherine MoremanDepartment of Pathology, University Hospitals Leicester, Leicester, LE1 5WW, UK.
Andrew PalmerBirmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.
Tessa Fulton-LieuwInstitute of Head and Neck Studies and Education (InHANSE), Department of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
Judith TaylorBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.
Kanchana RajaguruRadiology Department, Lister Hospital, Stevenage, SG1 4AB, UK.
Jasper BekkerDepartment of Radiology, Portsmouth Hospitals University NHS Trust, Portsmouth, PO6 3LY, UK.
Ram VaidhyanathDepartment of Radiology, Leicester Royal Infirmary, Leicester, LE1 5WW, UK.
Thaj RehmanDepartment of Radiology, Mid and South Essex NHS Foundation Trust, Basildon University Hospital, Basildon, Essex SS16 5NL, UK.
Jon DeeksBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.

Funding

National Institute for Health and Care ResearchNIHR Health Technology Assessment programme
6 · The paper itself

Abstract

introductionElaTION is a large multicenter pragmatic randomized 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-FNAC to inform and update current practice guidelines.

methodsAdults 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) vs US-FNAC.

resultsOf 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 = .37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, P < .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 < .0001). Yet 80/982 (8%) patients were discharged despite having U3-U5 scans with Thy1 (nondiagnostic) FNAC and no definitive diagnosis.Malignancy risk was higher in smaller nodules: < 10 mm 23/60 (38.3%), 10-20 mm 46/162 (28.4%), and >20 mm 80/466 (17.2%) (P < .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%) vs 42/113 (37.2%) respectively (P = .18).

conclusionUltrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the British Thyroid Association classification. However, findings also suggest caution regarding existing recommendations for conservative management of nondiagnostic (Thy1/Bethesda I) and atypical (Thy3a/Bethesda III) nodules. In those cases, ultrasound (U3-U5) features may help identify high-risk subgroups for more proactive management.

Indexed as

Endoscopic Ultrasound-Guided Fine Needle AspirationThyroid GlandThyroid NeoplasmsThyroid NoduleAdultAgedBiopsy, Fine-NeedleElasticity Imaging TechniquesFemaleHumansMaleMiddle AgedSensitivity and SpecificityUltrasonographydiagnosiselastographythyroid nodulesultrasound

Identifiers

PMID39359050
PMCPMC12187121

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.