FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Procedure: long axis FNA method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suspected thyroid nodule requiring diagnostic FNA, Exclusion Criteria: under or above age limit, no informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: long axis<br> | Procedure: long axis FNA method<br>* ). 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<br>* Other names: short axis FNA method;|
| Active Comparator: short axis<br> | Procedure: long axis FNA method<br>* ). 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<br>* Other names: short axis FNA method;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |