Viewing Study NCT06391021



Ignite Creation Date: 2024-05-06 @ 8:28 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06391021
Status: COMPLETED
Last Update Posted: 2024-05-02
First Post: 2024-04-25

Brief Title: Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Histopathology in Thyroid Nodule
Sponsor: Tribhuvan University Nepal
Organization: Tribhuvan University Nepal

Study Overview

Official Title: Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Post- Operative Histopathology in Thyroid Nodule
Status: COMPLETED
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TIRADS
Brief Summary: A thyroid nodule is a discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma Most thyroid nodules are benign with only 10 to 15 harboring cancer This is a prospective study conducted at the department of Ear Nose and Throat - Head and Neck Surgery ENT-HNS of Shree Birendra Hospital a tertiary heath care centre of Nepal Individuals visiting ENT-HNS outpatient department with thyroid nodules had undergone Ultrasonography USG of neck followed by Fine-Needle Aspiration Cytology FNAC from the thyroid nodules USG was reported by Thyroid Imaging Reporting and Data SystemTIRADS and FNAC by Bethesda system Thereafter patients were planned either for surgery either total thyroidectomy or hemithyroidectomy Post operative histopathology was correlated with preoperative FNAC and USG reports
Detailed Description: The main objective of this prospective cohort study is to know the correlation between pre- operative Bethesda with post- operative histopathology pre - operative TIRADS with post operative Histopathology and comparison of combined scoring of Bethesda and TIRADS with histopathology report It is of utmost importance to deep dive into thyroid nodules workup to detect malignant nodules as the management aspect of benign and malignant nodules has a vast difference Thyroid ultrasonography is useful for risk stratification of nodules and American College of Radiology Thyroid Imaging Reporting and Data System ACR TI-RADS classification provides recommendations for fine-needle aspiration cytology FNAC based on objective ultrasonography features of these nodules To maintain uniformity in reporting system FNA sample are categorized according to the Bethesda system Total 42 participants who met the inclusion criteria were included in the study Statistical Analysis was done using Statistical Package for the Social Science SPSS version 25 Analysis was done in the form of percentage and proportion and represented as table wherever necessary Spearmans correlation coefficient was used to evaluate the correlation between Bethesda and TIRADS Bethesda and histopathology and TIRADS and Bethesda system The P value was set at 005 for statistical significance

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None