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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879355
• Other study ID #: SJ-878
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: June 2022
• Source: Zealand University Hospital
• Contact: Tobias Andersen, MD
• Phone: 28409266
• Email: tobiasnicolaiandersen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• Spinal needle (25G)
Fine needle aspiration from thyroid nodules using a 25G spinal needle.
• Conventional fine needle (25G)
Fine needle aspiration from thyroid nodules using a conventional 25G fine needle

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Koege

Sponsors (3)

Lead Sponsor	Collaborator
Preben Homøe	Herlev Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic rate	The percentage of samples evaluated as "diagnostic" by the pathologist.	1 year
Secondary	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
Secondary	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
Secondary	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