Clinical trial NCT06391021: Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Histopathology in Thyroid Nodule
Official title: Comparison Between Combined Scoring of Bethesda Cytology and TIRADS Ultrasound With Post- Operative Histopathology in Thyroid Nodule
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodule
Keywords: FNAC
TIRADS
Bethesda
Histopathology
Lead sponsor: Tribhuvan University, Nepal
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the participants with thyroid nodules who met the inclusion criteria within the study period were enrolled in the study . Total 42 participants were included in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between Bethesda and TIRADS system
timeFrame: 6 months
measure: Performance measure of Bethesda classification
timeFrame: 6 months
measure: Performance measure of TIRADS classification
timeFrame: 6 months
Secondary outcomes:
measure: Sex-wise Distribution of thyroid nodule
timeFrame: 6 months
measure: Percentage of participants as per TIRADS classification
timeFrame: 6 months
measure: Number of participants as per histopathological examination
timeFrame: 6 months
measure: Number of participants as per Bethesda classification
timeFrame: 6 months
measure: Types of surgical procedures performed in terms of percentage
timeFrame: 6 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Shree Birendra Hospital
state: Bagmati
Study officials:
affiliation: Shree Birendra Hospital
name: Reeba Karki, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.