Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional fine needle (25G) | Device | — | UNRESOLVED |
| Spinal needle (25G) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Spinal needle
- description
- Fine needle aspiration from thyroid nodules using af spinal needle.
- interventionNames
- Device: Spinal needle (25G)
- type
- ACTIVE_COMPARATOR
- label
- Conventional fine needle
- description
- Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used.
- interventionNames
- Device: Conventional fine needle (25G)
Primary outcomes (1)
- measure
- Diagnostic rate
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAndersen TV, Bennedbaek FN, Pedersen J, Rosenorn MR, Kiss K, Lelkaitis G, Andersen L, Hegedus L, Lomholt AF, Hahn CH, Hvilsom GB, Homoe P, Todsen T. Spinal versus conventional fine needle for ultrasound-guided thyroid nodule biopsy: a protocol for a randomised clinical trial. Dan Med J. 2022 Jul 21;69(8):A03220165. PMID 35959834