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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
350
Fine needle aspiration from thyroid nodules using a 25G spinal needle.
Fine needle aspiration from thyroid nodules using a conventional 25G fine needle
Zealand University Hospital
Koege, Denmark
RECRUITINGDiagnostic rate
The percentage of samples evaluated as "diagnostic" by the pathologist.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 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
Time frame: About 2 years
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