Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules
Sponsor
Kafrelsheikh University (Other)
Overall Status
Completed
CT.gov ID
NCT04759053
Collaborator
Alexandria University (Other)
60
2
13
Study Details
Study Description
Brief Summary
The study aimed to determine the best intervention between Core biopsy and Fine needle aspiration in diagnosis of thyroid malignancy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Effectiveness of Core-Needle US Guided Biopsy as Primary Tool For Diagnosis of Thyroid Nodules, A Prospective Study
Actual Study Start Date
:
Jan 1, 2017
Actual Primary Completion Date
:
Jan 1, 2018
Actual Study Completion Date
:
Feb 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: FNB
|
Procedure: FNB
Fine needle aspiration from the nodules
Procedure: Core biopsy
Core biopsy from thyroid nodules
|
| Active Comparator: Core biopsy
|
Procedure: FNB
Fine needle aspiration from the nodules
Procedure: Core biopsy
Core biopsy from thyroid nodules
|
Outcome Measures
Primary Outcome Measures
- Number of samples in FNB and CNB matching the final pathology [7 days]
Comparing number of samples in FNB and CNB that make same diagnosis as the final postoperative pathology
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kafrelsheikh University
- Alexandria University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ahmed Aouf,
Dr, Assistant lecturer of general surgery,
Kafrelsheikh University
ClinicalTrials.gov Identifier:
NCT04759053
Other Study ID Numbers:
- 124569124577
First Posted:
Feb 17, 2021
Last Update Posted:
Feb 17, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Aouf,
Dr, Assistant lecturer of general surgery,
Kafrelsheikh University
Additional relevant MeSH terms: