FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study

NCT04458233 — Not applicable, Unknown, 200 participants, Ziv Hospital

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Registry	NCT04458233
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, diagnostic
Enrollment	200 (Estimated)
Sponsor	Ziv Hospital (Other gov)
Conditions	Thyroid Nodule
Interventions	long axis FNA method (Procedure)
Dates	start 2020-06-01, primary completion 2021-06-01 (estimated), completion 2021-07-01 (estimated), first posted 2020-07-07, last updated 2020-07-07
Locations	1 site in Israel

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
long axis	Active comparator	Procedure: long axis FNA method
short axis	Active comparator	Procedure: long axis FNA method

long axis FNA method (Procedure), also known as short 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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* suspected thyroid nodule requiring diagnostic FNA,

Exclusion Criteria:

* under or above age limit, no informed consent

+Locations (1)

Facility	City	Country	Status
Ziv Medical Center	Safed	Israel	Recruiting