Thyroid disease

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

J Clin Endocrinol MetabPublished Diagnostic accuracy study

Authors' conclusion

Ultrasound 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.

Study context

Population
Adults with single or multiple thyroid nodules without previous FNAC, 18 hospitals in England688 analysed
Participants
982 adults
Comparison
US alone vs US-guided FNAC
Outcome
Accuracy (sensitivity and specificity) of US alone vs US-FNAC
Methodological detailssecondary outcomes of the ElaTION randomised controlled trial, multicenter, pragmatic, 18 secondary/tertiary hospitals in England
  • Secondary outcomes of the ElaTION randomised controlled trial
  • Multicenter
  • Pragmatic
  • 18 secondary/tertiary hospitals in England

Performance

As reported in the abstract

Test or modelSensitivitySpecificity
US0.91 (95% CI, 0.85-0.97)0.48
US-FNAC0.87 (95% CI, 0.80-0.95)0.67

Sensitivity

US0.91 (95% CI, 0.85-0.97)
US-FNAC0.87 (95% CI, 0.80-0.95)

Specificity

US0.48
US-FNAC0.67
  • US vs US-FNAC: P = 0.37 — sensitivity the same
  • US vs US-FNAC: P < 0.0001 — lower specificity with US

Further findings

Malignancy rate on histology in benign-classified nodules

Benign on US (U2)
9/263 (3.42%)
Benign on cytology (Thy2)
15/353 (4.25%)
Benign on both (U2, Thy2)
3/210 (1.43%)

Malignancy risk by US category

U3
68/304 (22.4%)
U4
43/83 (51.8%)
U5
29/38 (76.3%)
P
P < 0.0001

Discharged despite U3-U5 scans with Thy1 (nondiagnostic) FNAC and no definitive diagnosis

Patients discharged
80/982 (8%)

Malignancy risk by nodule size

< 10 mm
23/60 (38.3%)
10-20 mm
46/162 (28.4%)
>20 mm
80/466 (17.2%)
P
P < 0.0001
  • Higher in smaller nodules

Malignancy risk, Thy3a vs Thy3/3f cytology

Thy3a
27/95 (28.4%)
Thy3/3f
42/113 (37.2%)
P
P = 0.18
  • Similar malignancy risk

Original publication

Diagnostic Performance of Ultrasound vs Ultrasound-Guided FNAC in Thyroid Nodules: Data From the ElaTION Trial. J Clin Endocrinol Metab. Published 3 October 2024. doi:10.1210/clinem/dgae682

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