Back to resultsEffectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules
Primary Purpose
Thyroid Nodule, Thyroid Diseases, Thyroid Gland; Node
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FNB
Core biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodule focused on measuring Thyroid nodule, Core needle biopsy, FNB
Eligibility Criteria
Inclusion Criteria:
- patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with TIRADS category III or higher.
Exclusion Criteria:
- Patients with a history of hemodynamic instability or inadequate coagulation profile were excluded
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
FNB
Core biopsy
Arm Description
Outcomes
Primary Outcome Measures
Number of samples in FNB and CNB matching the final pathology
Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology
Secondary Outcome Measures
Full Information
NCT ID
NCT04759053
First Posted
February 9, 2021
Last Updated
February 16, 2021
Sponsor
Kafrelsheikh University
Collaborators
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT04759053
Brief Title
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules
Official Title
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules, A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
Collaborators
Alexandria University
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
The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Thyroid Diseases, Thyroid Gland; Node
Keywords
Thyroid nodule, Core needle biopsy, FNB
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FNB
Arm Type
Active Comparator
Arm Title
Core biopsy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
FNB
Intervention Description
Fine needle aspiration from the nodules
Intervention Type
Procedure
Intervention Name(s)
Core biopsy
Intervention Description
Core biopsy from thyroid nodules
Primary Outcome Measure Information:
Title
Number of samples in FNB and CNB matching the final pathology
Description
Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with nodules larger than 1 cm in diameter and suspicious ultrasound criteria with TIRADS category III or higher.
Exclusion Criteria:
Patients with a history of hemodynamic instability or inadequate coagulation profile were excluded
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules
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