FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study
Primary Purpose
Thyroid Nodule
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
long axis FNA method
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodule
Eligibility Criteria
Inclusion Criteria:
- suspected thyroid nodule requiring diagnostic FNA,
Exclusion Criteria:
- under or above age limit, no informed consent
Sites / Locations
- Ziv Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
long axis
short axis
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04458233
Brief Title
FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study
Official Title
FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
long axis
Arm Type
Active Comparator
Arm Title
short axis
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
long axis FNA method
Other Intervention Name(s)
short axis FNA method
Intervention Description
). 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
Primary Outcome Measure Information:
Title
amount of FNAC non diagnostic Bethesda 1 results
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suspected thyroid nodule requiring diagnostic FNA,
Exclusion Criteria:
under or above age limit, no informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yaniv avraham
Phone
972-4-6828894
Email
yanivavr1@gmail.com
Facility Information:
Facility Name
Ziv Medical Center
City
Zefat
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonid Livshits, MD
Email
surger79@gmail.com
First Name & Middle Initial & Last Name & Degree
YANIV AVRAHAM
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no individual data to be shared
Learn more about this trial
FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study
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