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

Preben Homøe

Status: Enrolling

Conditions: Thyroid Nodule

Treatments: Device: Conventional fine needle (25G); Device: Spinal needle (25G)

Study type: Interventional

Funder types: Other

Identifiers

NCT04879355

SJ-878

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Spinal needle

Experimental group

Description:

Fine needle aspiration from thyroid nodules using af spinal needle.

Treatment:

Device: Spinal needle (25G)

Conventional fine needle

Active Comparator group

Description:

Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used.

Treatment:

Device: Conventional fine needle (25G)