Spinal Needles in Ultrasound-guided Fine Needle Aspirations From Thyroid Nodules

The Use of Spinal Needles for Ultrasound-guided Fine Needle Aspiration From Thyroid Nodules - a Protocol for a Multicentre Randomised Controlled Trial

This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are diagnostic accuracy, patient's experienced pain and complication rates.

Inclusion Criteria:

1. ≥18 years of age.

2. Patients referred for evaluation of a cold nodule on thyroid scintigraphy and with EU-TIRADS score of 3 or higher.

   • Score 3 and > 20 mm in size.
   • Score 4 and >15 mm in size.
   • Score 5 and >10 mm in size.

3. Clinical suspicion of thyroid cancer:

   • PET-positive thyroid tumor.
   • Thyroid tumor and palsy of the recurrent laryngeal nerve.
   • Rapidly growing thyroid tumor.
   • Hard and/or immobile thyroid tumor.
   • Tumor in the thyroid with suspicious lymph nodes.

Exclusion Criteria:

• Previous participation in the study.
• Language or other barriers not allowing adequate information.