FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study

Thyroid Nodule Clinical Trial

Official title:

FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458233
• Other study ID #: 0006-20
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2020
• Source: Ziv Hospital
• Contact: yaniv avraham
• Phone: 972-4-6828894
• Email: yanivavr1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• suspected thyroid nodule requiring diagnostic FNA,

Exclusion Criteria:

• under or above age limit, no informed consent

Related Conditions & MeSH terms

• Thyroid Nodule

Intervention

Procedure:
• long axis FNA method
). A "long-axis" view (i.e., a longitudinal image of the needle) is obtained by placing the US probe in a parallel position relative to the course of the needle. Short-axis and long-axis views can be used for both US assistance and guidance of FNA procedure. Correspondingly, approaching the nodule with the needle from the lateral or frontal aspect results in either a long axis or short axis view of the needle on the US screen

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of FNAC non diagnostic Bethesda 1 results	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	1 year