Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With TIRADS Score and Surgical Pathology

Thyroid Nodule Clinical Trial

— TIRADS  

Official title:

Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With Thyroid Imaging Reporting and Data System Score and Surgical Pathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488640
• Other study ID #: 8131643
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators retrospectively reviewed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. The investigators evaluated patients' thyroid ultrasonography reports and determined Thyroid Imaging Reporting and Data System scores (TIRADS score: 1-Benign, 2- very low malignant) risk, 3-low risk, 4-medium risk, 5 -malignant high risk). The investigators evaluated patients 'existing thyroid fine needle aspiration biopsy (FNAB) reports and recorded the patients' cytology results (benign, malignant).

Documents of 88 patients who were included in the study and who underwent thyroidectomy were reviewed.Pathology reports of these patients were evaluated and surgical pathology was determined as benign in 58 patients and malignant in 30 patients.

Then, a statistical study was performed between the cor needle biopsy (CNB) results of these participants and the surgical pathology and TI-RADS scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 85 Years

Eligibility

Inclusion Criteria:

• Having a thyroid nodule

• Being both a thyroid needle and a core biopsy

Exclusion Criteria:

• Child patients

• Pregnant patients

• Patients without a thyroid needle biopsy

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Procedure:
• Thyroid biopsy with ultrasound
Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

References & Publications (5)

Hahn SY, Shin JH, Oh YL, Park KW, Lim Y. Comparison Between Fine Needle Aspiration and Core Needle Biopsy for the Diagnosis of Thyroid Nodules: Effective Indications According to US Findings. Sci Rep. 2020 Mar 18;10(1):4969. doi: 10.1038/s41598-020-60872- — View Citation

Kim SY, Lee HS, Moon J, Kim EK, Moon HJ, Yoon JH, Kwak JY. Fine-needle aspiration versus core needle biopsy for diagnosis of thyroid malignancy and neoplasm: a matched cohort study. Eur Radiol. 2017 Feb;27(2):801-811. doi: 10.1007/s00330-016-4424-1. Epub — View Citation

Lew JI, Snyder RA, Sanchez YM, Solorzano CC. Fine needle aspiration of the thyroid: correlation with final histopathology in a surgical series of 797 patients. J Am Coll Surg. 2011 Jul;213(1):188-94; discussion 194-5. doi: 10.1016/j.jamcollsurg.2011.04.02 — View Citation

Singaporewalla RM, Hwee J, Lang TU, Desai V. Clinico-pathological Correlation of Thyroid Nodule Ultrasound and Cytology Using the TIRADS and Bethesda Classifications. World J Surg. 2017 Jul;41(7):1807-1811. doi: 10.1007/s00268-017-3919-5. — View Citation

Singh Ospina N, Brito JP, Maraka S, Espinosa de Ycaza AE, Rodriguez-Gutierrez R, Gionfriddo MR, Castaneda-Guarderas A, Benkhadra K, Al Nofal A, Erwin P, Morris JC, Castro MR, Montori VM. Diagnostic accuracy of ultrasound-guided fine needle aspiration biop — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the distribution of patients according to thyroid biopsy results.	Thyroid biopsy results (benign, malignant) will be compared with % of patients with these results. It will be analyzed statistically.	4-year results were included.
Primary	Examination of TIRADS score distribution according to thyroid biopsy results.	Thyroid biopsy results (benign, malignant) will be compared with the percentage of patients who fit the TIRADS score distribution (1-5). It will be analyzed statistically.	4-year results were included.
Primary	Evaluation of the compliance of TI-RADS scores with surgical pathology reports.	Surgical pathology results (benign, malignant) and TI-RADS scores (1 to 5) will be compared with% of patients matching the distribution (1-5). It will be analyzed statistically.	4-year results were included.
Primary	Evaluation of the distribution of thyroid biopsy results and surgical pathology results.	The % of patients who match the distribution of thyroid biopsy results (benign, malignant) and surgical pathology results (benign, malignant) will be compared. It will be analyzed statistically.	4-year results were included.