Thyroid Nodular Disease
Conditions
Brief summary
This randomized study compares patient pain and comfort during ultrasound-guided thyroid fine needle biopsy using 21-gauge versus 27-gauge needles. Patients with thyroid nodules were randomly assigned to one of two needle sizes. Pain intensity was measured immediately after the procedure using a 0-100 Visual Analog Scale. The study was conducted at İzmir Atatürk Training and Research Hospital between January 2024 and March 2024. The aim is to determine which needle size causes less pain and better patient comfort during the biopsy procedure.
Detailed description
This prospective, randomized, single-blind clinical trial compares 21-gauge and 27-gauge needles for ultrasound-guided fine-needle biopsy of thyroid nodules. Participants are randomly assigned in a 1:1 ratio. The study aims to evaluate whether needle gauge affects patient pain and biopsy performance. Detailed eligibility criteria, outcome measures, and statistical analyses are provided in their respective sections.
Interventions
PROCEDUREThyroid fine needle biopsy with 21-gauge needle
4\. Ultrasound-guided fine needle biopsy performed using a 21-gauge needle for thyroid nodule cytology
PROCEDUREThyroid fine needle biopsy with 27-gauge needle
Ultrasound-guided fine needle biopsy performed using a 27-gauge needle for thyroid nodule cytology
Sponsors
Izmir Ataturk Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* Thyroid nodules requiring ultrasound-guided FNB with a maximum diameter ≥10 mm, * Intraglandular nodules with relatively central location within the thyroid gland
Exclusion criteria
* Patient refusal to provide informed consent, * History of bleeding tendency or use of anticoagulant medication, * Substernal or subclavicular localization of the lesion in cases of large goiter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score immediately after biopsy | In 5 minutes after the procedure | Pain intensity measured using 100-mm Visual Analog Scale immediately after completion of ultrasound-guided thyroid fine needle biopsy. Higher scores indicate worse pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Adequacy Rate. | Time Frame: Within 14 days after biopsy | Percentage of biopsy specimens considered adequate for cytopathological evaluation according to the Bethesda System for Reporting Thyroid Cytopathology |
Countries
Turkey (Türkiye)
Outcome results
None listed