Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal needle | Experimental | Fine needle aspiration from thyroid nodules using af spinal needle. |
|
| Conventional fine needle | Active Comparator | Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal needle (25G) | Device | Fine needle aspiration from thyroid nodules using a 25G spinal needle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic rate | The percentage of samples evaluated as "diagnostic" by the pathologist. | 1 year |
| 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. |
Not provided
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.
Clinical suspicion of thyroid cancer:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Andersen, MD | Contact | 28409266 | 0045 | tobiasnicolaiandersen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tobias Andersen, MD | Zealand University Hospital, Køge, Denmark. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Recruiting | Koege | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35959834 | Derived | Andersen TV, Bennedbaek FN, Pedersen J, Rosenorn MR, Kiss K, Lelkaitis G, Andersen L, Hegedus L, Lomholt AF, Hahn CH, Hvilsom GB, Homoe P, Todsen T. Spinal versus conventional fine needle for ultrasound-guided thyroid nodule biopsy: a protocol for a randomised clinical trial. Dan Med J. 2022 Jul 21;69(8):A03220165. |
Not provided
Not provided
Data collected in this trial can be shared upon request from other researchers after publication.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
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.
Not provided
Not provided
The patients and the pathologists are blinded to the intervention, while the clinicians performing the FNAs are not.
| Conventional fine needle (25G) | Device | Fine needle aspiration from thyroid nodules using a conventional 25G fine needle |
|
| 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |