Clinical trial NCT04488640: Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With TIRADS Score and Surgical Pathology
Official title: Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With Thyroid Imaging Reporting and Data System Score and Surgical Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodule
Keywords: TI-RADS score
Thyroid fine needle aspiration biopsy
Thyroid core needle biopsy
Surgical pathology
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 4
Sex: ALL
Minimum age (years): 24
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thyroid biopsy data of 691 women and 69 men aged between 24-85 years were evaluated.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the distribution of patients according to thyroid biopsy results.
timeFrame: 4-year results were included.
measure: Examination of TIRADS score distribution according to thyroid biopsy results.
timeFrame: 4-year results were included.
measure: Evaluation of the compliance of TI-RADS scores with surgical pathology reports.
timeFrame: 4-year results were included.
measure: Evaluation of the distribution of thyroid biopsy results and surgical pathology results.
timeFrame: 4-year results were included.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bezmialem Vakif University
name: Beyza Benturk, Dr
role: STUDY_CHAIR
References:
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 biopsy for thyroid malignancy: systematic review and meta-analysis. Endocrine. 2016 Sep;53(3):651-61. doi: 10.1007/s12020-016-0921-x. Epub 2016 Apr 12.
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.
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.2011.04.029. Epub 2011 May 20.
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 2016 Jun 3.
citation: 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-z.