FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study

Not Applicable

• Conditions: Thyroid Nodule
• Interventions: Procedure: long axis FNA method

• Registration Number: NCT04458233
• Lead Sponsor: Ziv Hospital

Brief Summary

Ultrasound-guided fine needle aspiration cytology (FNAC) has been proven to be an accurate and efficient tool in thyroid nodule evaluation. Thyroid nodule aspiration is performed by the use of either two techniques; the short axis approach by which only the tip of the needle is observed, or the long axis approach by which the entire needle is observed. Controversial remains of which approach produces better diagnostic adequacy and less non-diagnostic (Bethesda category I) results.

Detailed Description

200 patients presenting electively for thyroid FNA will recruited. Patients will be randomly assigned to two groups: short axis or long axis FNA. FNA will be performed by a single physician at the Ziv medical center ENT clinics.

patient group randomization will be performed according to a random number sequence generated by the SPSS system. Randomization will be performed on admission prior to the procedure.

FNAC sample diagnosis will be performed according to the regular protocol. Laboratory personnel will be blinded to the sample group.

sample results will be compared and analyzed. A P value of less than 0.05 will be regarded as significant.

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• suspected thyroid nodule requiring diagnostic FNA,

Exclusion Criteria

• under or above age limit, no informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
long axis	long axis FNA method	-
short axis	long axis FNA method	-

Primary Outcome Measures

Name	Time	Method
amount of FNAC non diagnostic Bethesda 1 results	1 year	The exact preferred technique for performing Ultrasound Guided FNA is unclear. The correct positioning of the US probe and or the FNA needle could have a marked effect on the diagnostic results of the biopsy

Trial Locations

Locations (1)

Ziv Medical Center; 🇮🇱 Zefat, Israel