Thyroid Nodule
Conditions
Brief 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.
Interventions
DEVICESpinal needle (25G)
Fine needle aspiration from thyroid nodules using a 25G spinal needle.
DEVICEConventional fine needle (25G)
Fine needle aspiration from thyroid nodules using a conventional 25G fine needle
Sponsors
Herlev Hospital
Rigshospitalet, Denmark
Preben Homøe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patients and the pathologists are blinded to the intervention, while the clinicians performing the FNAs are not.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic rate | 1 year | The percentage of samples evaluated as diagnostic by the pathologist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | Till 1 month after last inclusion. Corresponding to about 1 year | 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. |
| Pain assessment | About 2 years | 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. |
| Diagnostic accuracy | About 2 years | Cytology from FNAB is compared with histology in the subgroup of patients who undergo surgery during the course of the study |
Countries
Denmark
Contacts
Primary ContactTobias Andersen, MD
Outcome results
None listed