Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Histopathology in Thyroid Nodule

Completed

• Conditions: Thyroid Nodule

• Registration Number: NCT06391021
• Lead Sponsor: Tribhuvan University, Nepal

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 System(TIRADS) 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. Spearman's 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 \< 0.05 for statistical significance.

Study Timeline

• Study Start: 2022-06-20
• Primary Completion: 2022-11-25
• Study Completion: 2023-02-15
• Status Verified: 2024-04
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 1.Patients presenting to Ear Nose and Throat, Head and Neck Surgery Department with thyroid nodules undergoing hemithyroidectomy or total thyroidectomy within the study period

Exclusion Criteria

• 1.Patients refusing to give consent for the study. 2.Patients with already known case of thyroid malignancies proven by histopathological reports.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between Bethesda and TIRADS system	6 months	Correlation between Bethesda and TIRADS system in terms of number of participants belonging to each category
Performance measure of TIRADS classification	6 months	Performance measure of TIRADS classification in terms of percentage
Performance measure of Bethesda classification	6 months	Performance measure of Bethesda classification in terms of percentage

Secondary Outcome Measures

Name	Time	Method
Number of participants as per Bethesda classification	6 months	Number of participants as per Bethesda classification
Types of surgical procedures performed in terms of percentage	6 months	Types of surgical procedures performed in terms of percentage
Percentage of participants as per TIRADS classification	6 months	Percentage of participants as per TIRADS classification
Sex-wise Distribution of thyroid nodule	6 months	Sex-wise Distribution of thyroid nodule in percentage
Number of participants as per histopathological examination	6 months	Number of participants as per histopathological examination

Trial Locations

Locations (1)

Shree Birendra Hospital; 🇳🇵 Kathmandu, Bagmati, Nepal