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NCT Number: NCT07683039

Thyroid Fine Needle Biopsy and Impact on Pain and Diagnostic Adequacy

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.

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Key information

Conditions

Thyroid Nodular Disease

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İzmir Atatürk Training and Education Hospital

Izmir, 35620, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thyroid fine needle biopsy with 21-gauge needle

Procedure
  • Ultrasound-guided fine needle biopsy performed using a 21-gauge needle for thyroid nodule cytology

Thyroid fine needle biopsy with 27-gauge needle

Procedure

Ultrasound-guided fine needle biopsy performed using a 27-gauge needle for thyroid nodule cytology

Primary outcomes

  1. Pain score immediately after biopsy

    Time frame: 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 outcomes

  1. Diagnostic Adequacy Rate.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Izmir Ataturk Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: THY-BPSY

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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