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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06391021
Other study ID # 628
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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