Thyroid Nodular DiseaseTHY-BPSYNCT07683039
Thyroid Fine Needle Biopsy and Impact on Pain and Diagnostic Adequacy
A study testing Thyroid fine needle biopsy with 21-gauge needle and Thyroid fine needle biopsy with 27-gauge needle in people with Thyroid Nodular Disease, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Thyroid Nodular Disease
- What is being tested?
- Thyroid fine needle biopsy with 21-gauge needle and Thyroid fine needle biopsy with 27-gauge needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2024to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thyroid nodules requiring ultrasound-guided FNB with a maximum diameter ≥10 mm,
- Intraglandular nodules with relatively central location within the thyroid gland
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Atatürk Training and Education Hospital
Izmir, 35620
About this study
Official 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
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.
Read the 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.
- Conditions
- Thyroid Nodular Disease
- Being tested
- Thyroid fine needle biopsy with 21-gauge needle, Thyroid fine needle biopsy with 27-gauge needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid fine needle biopsy with 21-gauge needleProcedure or surgery
- Ultrasound-guided fine needle biopsy performed using a 21-gauge needle for thyroid nodule cytology
Thyroid fine needle biopsy with 27-gauge needleProcedure or surgery
Ultrasound-guided fine needle biopsy performed using a 27-gauge needle for thyroid nodule cytology
| Study group | Role | What they receive |
|---|---|---|
| 21-gauge needle group | Experimental | Patients received ultrasound-guided thyroid fine needle biopsy using 21-gauge needle Receives: Procedure: Thyroid fine needle biopsy with 21-gauge needle |
| 27-gauge needle group | Experimental | Patients received ultrasound-guided thyroid fine needle biopsy using 27-gauge needle Receives: Procedure: Thyroid fine needle biopsy with 27-gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: In 5 minutes after the procedure
Secondary outcomes (1)
Diagnostic Adequacy Rate.
Percentage of biopsy specimens considered adequate for cytopathological evaluation according to the Bethesda System for Reporting Thyroid Cytopathology
Measured: Time Frame: Within 14 days after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start19 Jan 2024
- Primary completion30 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Nodular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yağtu, MD, Izmir Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683039
- Sponsor's protocol ID
- 0001-2024
- Acronym
- THY-BPSY
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07683039
- Acronym / sponsor ID
- THY-BPSY / 0001-2024
- Conditions
- Thyroid Nodular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Izmir Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 21-gauge needle group | Experimental | Procedure: Thyroid fine needle biopsy with 21-gauge needlePatients received ultrasound-guided thyroid fine needle biopsy using 21-gauge needle |
| 27-gauge needle group | Experimental | Procedure: Thyroid fine needle biopsy with 27-gauge needlePatients received ultrasound-guided thyroid fine needle biopsy using 27-gauge needle |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thyroid nodules requiring ultrasound-guided FNB with a maximum diameter ≥10 mm,
- Intraglandular nodules with relatively central location within the thyroid gland
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid fine needle biopsy with 21-gauge needle4. Ultrasound-guided fine needle biopsy performed using a 21-gauge needle for thyroid nodule cytology | Procedure or surgery | 21-gauge needle group |
| Thyroid fine needle biopsy with 27-gauge needleUltrasound-guided fine needle biopsy performed using a 27-gauge needle for thyroid nodule cytology | Procedure or surgery | 27-gauge needle group |
Primary outcome
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
1 secondary outcome
Diagnostic Adequacy Rate.
Time frame: Time Frame: Within 14 days after biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Thyroid Nodular Disease
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
RecruitingPhase 3
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
Hyperthyroidism
RecruitingObservational study
Dysphagia After Thyroidectomy
Goiter, Thyroid Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroid fine needle biopsy with 21-gauge needle and Thyroid fine needle biopsy with 27-gauge needle in people with Thyroid Nodular Disease, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score immediately after biopsy (time frame: In 5 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.