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Clinical Trials/NCT04458233
NCT04458233
Unknown
Not Applicable

FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study

Ziv Hospital1 site in 1 country200 target enrollmentJune 1, 2020
ConditionsThyroid Nodule

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Nodule
Sponsor
Ziv Hospital
Enrollment
200
Locations
1
Primary Endpoint
amount of FNAC non diagnostic Bethesda 1 results
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
July 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ziv Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • suspected thyroid nodule requiring diagnostic FNA,

Exclusion Criteria

  • under or above age limit, no informed consent

Outcomes

Primary Outcomes

amount of FNAC non diagnostic Bethesda 1 results

Time Frame: 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

Study Sites (1)

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