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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Device: Spinal needle (25G)
* Device: Conventional fine needle (25G)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients are randomised at a 1:1-ratio to one of two parallel groups, and all patients are included in the analysis on an intention-to-treat basis.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal needle<br>Fine needle aspiration from thyroid nodules using af spinal needle. | Device: Spinal needle (25G)<br>* Fine needle aspiration from thyroid nodules using a 25G spinal needle.<br>|
| Active Comparator: Conventional fine needle<br>Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used. | Device: Conventional fine needle (25G)<br>* Fine needle aspiration from thyroid nodules using a conventional 25G fine needle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic rate | The percentage of samples evaluated as diagnostic by the pathologist. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Complications, such as infections, bleedings or hematomas requiring treatment or admission, recurrent nerve injury and Horner's syndrome, will be recorded during the procedure. All patients are instructed to contact the department responsible for their management if they suspect complications. These will then be documented in the patient's medical record. At the end of the study period, the patient's medical records will be reviewed for admissions or contacts concerning complications. | Till 1 month after last inclusion. Corresponding to about 1 year | 
| Pain assessment | Pain is assessed using the VAS (Visual Analog Scale) immediate after the procedure. The score is ranging from 0 to 10 with higher numbers indicating a more painful procedure. | About 2 years | 
| Diagnostic accuracy | Cytology from FNAB is compared with histology in the subgroup of patients who undergo surgery during the course of the study | About 2 years |