Thyroid Fine Needle Biopsy and Impact on Pain and Diagnostic Adequacy
THY-BPSY
The Effect of Using Different Needle Sizes on Patient Comfort and Pain During the Sonographically Guided Fine Needle Biopsy of Thyroid Nodules: A Randomized Controlled Trial
1 other identifier
interventional
159
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedFirst Submitted
Initial submission to the registry
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 6, 2026
CompletedJuly 30, 2026
July 1, 2026
2 months
June 22, 2026
July 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pain score immediately after biopsy
Pain intensity measured using 100-mm Visual Analog Scale immediately after completion of ultrasound-guided thyroid fine needle biopsy. Higher scores indicate worse pain
In 5 minutes after the procedure
Secondary Outcomes (1)
Diagnostic Adequacy Rate.
Time Frame: Within 14 days after biopsy
Study Arms (2)
21-gauge needle group
EXPERIMENTALPatients received ultrasound-guided thyroid fine needle biopsy using 21-gauge needle
27-gauge needle group
EXPERIMENTALPatients received ultrasound-guided thyroid fine needle biopsy using 27-gauge needle
Interventions
4\. Ultrasound-guided fine needle biopsy performed using a 21-gauge needle for thyroid nodule cytology
Ultrasound-guided fine needle biopsy performed using a 27-gauge needle for thyroid nodule cytology
Eligibility Criteria
You may qualify if:
- Thyroid nodules requiring ultrasound-guided FNB with a maximum diameter ≥10 mm,
- Intraglandular nodules with relatively central location within the thyroid gland
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İzmir Atatürk Training and Education Hospital
Izmir, 35620, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, MD
Study Record Dates
First Submitted
June 22, 2026
First Posted
July 6, 2026
Study Start
January 19, 2024
Primary Completion
March 30, 2024
Study Completion
March 31, 2024
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share