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

NCT06391021 | Completed

• 1 other identifier: 628
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule

Keywords

FNAC; TIRADS; Bethesda; Histopathology

Outcome Measures

Primary Outcomes (3)

• Correlation between Bethesda and TIRADS system

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

  6 months

• Performance measure of Bethesda classification

  Performance measure of Bethesda classification in terms of percentage

  6 months

• Performance measure of TIRADS classification

  Performance measure of TIRADS classification in terms of percentage

  6 months

Secondary Outcomes (5)

• Sex-wise Distribution of thyroid nodule

  6 months

• Percentage of participants as per TIRADS classification

  6 months

• Number of participants as per histopathological examination

  6 months

• Number of participants as per Bethesda classification

  6 months

• Types of surgical procedures performed in terms of percentage

  6 months

Eligibility Criteria

• Age: 20 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tribhuvan University, Nepal: lead

Study Sites (1)

Shree Birendra Hospital

Kathmandu, Bagmati, +977, Nepal

Location

Related 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.

  PMID: 26462967 BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Reeba Karki, MS

  Shree Birendra Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intern Doctor, Department of Ear, Nose and Throat Head and Neck Surgery

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: June 20, 2022
• Primary Completion: November 25, 2022
• Study Completion: February 15, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)