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Completed

NCT Number: NCT06391021

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

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.

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Key information

Age range

20 year–66 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shree Birendra Hospital

Kathmandu, Bagmati, +977, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation between Bethesda and TIRADS system

    Time frame: 6 months

    Correlation between Bethesda and TIRADS system in terms of number of participants belonging to each category

  2. Performance measure of Bethesda classification

    Time frame: 6 months

    Performance measure of Bethesda classification in terms of percentage

  3. Performance measure of TIRADS classification

    Time frame: 6 months

    Performance measure of TIRADS classification in terms of percentage

Secondary outcomes

  1. Sex-wise Distribution of thyroid nodule

    Time frame: 6 months

    Sex-wise Distribution of thyroid nodule in percentage

  2. Percentage of participants as per TIRADS classification

    Time frame: 6 months

    Percentage of participants as per TIRADS classification

  3. Number of participants as per histopathological examination

    Time frame: 6 months

    Number of participants as per histopathological examination

  4. Number of participants as per Bethesda classification

    Time frame: 6 months

    Number of participants as per Bethesda classification

  5. Types of surgical procedures performed in terms of percentage

    Time frame: 6 months

    Types of surgical procedures performed in terms of percentage

Sponsors and collaborators

Lead sponsor

Tribhuvan University, Nepal

Other

Registry information

Official study title

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

Acronym: TIRADS

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 30, 2024
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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