NCT04879355

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Preben Homøe · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Thyroid Nodule

Interventions

Type	Name	Description
DEVICE	Spinal needle (25G)	Fine needle aspiration from thyroid nodules using a 25G spinal needle.
DEVICE	Conventional fine needle (25G)	Fine needle aspiration from thyroid nodules using a conventional 25G fine needle

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-05-01
• Completion: 2023-11-01
• First posted: 2021-05-10
• Last updated: 2022-07-05

Locations

1 site across 1 country: Denmark