FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 30, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJuly 7, 2020
June 1, 2020
1 year
June 30, 2020
June 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
long axis
ACTIVE COMPARATORshort axis
ACTIVE COMPARATORInterventions
). 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
Eligibility Criteria
You may qualify if:
- suspected thyroid nodule requiring diagnostic FNA,
You may not qualify if:
- under or above age limit, no informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ziv Hospitallead
Study Sites (1)
Ziv Medical Center
Safed, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 7, 2020
Study Start
June 1, 2020
Primary Completion
June 1, 2021
Study Completion
July 1, 2021
Last Updated
July 7, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share
no individual data to be shared