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

Not Applicable

• Conditions: Thyroid Nodule

• Registration Number: NCT04879355
• Lead Sponsor: Preben Homøe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-07
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-10
• Study Start: 2021-11-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-05
• Primary Completion: 2023-05-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic rate	1 year	The percentage of samples evaluated as "diagnostic" by the pathologist.

Secondary Outcome Measures

Name	Time	Method
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.
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
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.

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Koege, Denmark

Zealand University Hospital

🇩🇰Koege, Denmark

Tobias Andersen, MD

Contact

28409266

tvennervald@gmail.com