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

Thyroid Nodule Clinical Trial

— TIRADS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06391021
• Other study ID #: 628
• Status: Completed
• Start date: June 20, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: April 2024
• Source: Tribhuvan University, Nepal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 15, 2023
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Locations

Country	Name	City	State
Nepal	Shree Birendra Hospital	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

References & Publications (1)

Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between Bethesda and TIRADS system	Correlation between Bethesda and TIRADS system in terms of number of participants belonging to each category	6 months
Primary	Performance measure of Bethesda classification	Performance measure of Bethesda classification in terms of percentage	6 months
Primary	Performance measure of TIRADS classification	Performance measure of TIRADS classification in terms of percentage	6 months
Secondary	Sex-wise Distribution of thyroid nodule	Sex-wise Distribution of thyroid nodule in percentage	6 months
Secondary	Percentage of participants as per TIRADS classification	Percentage of participants as per TIRADS classification	6 months
Secondary	Number of participants as per histopathological examination	Number of participants as per histopathological examination	6 months
Secondary	Number of participants as per Bethesda classification	Number of participants as per Bethesda classification	6 months
Secondary	Types of surgical procedures performed in terms of percentage	Types of surgical procedures performed in terms of percentage	6 months