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

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Completed
CT.gov ID
NCT04488640
Collaborator
(none)
4
Enrollment
40
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thyroid biopsy with ultrasound

Study Design

Study Type:
Observational
Actual Enrollment :
4 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With Thyroid Imaging Reporting and Data System Score and Surgical Pathology
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Thyroid fine needle aspiration biopsy group

A group of 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis.

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.
Other Names:
  • Total thyroidectomy

    		•
    Thyroid core needle aspiration biopsy group

    A patient group with 760 people who had a thyroid nodule and who had a thyroid fine needle aspiration biopsy for diagnosis and who underwent a core needle biopsy again. A total thyroidectomy was performed in 88 of these patients. Surgical pathology results, core needle results and TIRADS scores were compared.

    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.
    Other Names:
  • Total thyroidectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the distribution of patients according to thyroid biopsy results. [4-year results were included.]

      Thyroid biopsy results (benign, malignant) will be compared with % of patients with these results. It will be analyzed statistically.

    2. Examination of TIRADS score distribution according to thyroid biopsy results. [4-year results were included.]

      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.

    3. Evaluation of the compliance of TI-RADS scores with surgical pathology reports. [4-year results were included.]

      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. Evaluation of the distribution of thyroid biopsy results and surgical pathology results. [4-year results were included.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bezmialem Vakif University

    Investigators

    • Study Chair: Beyza Benturk, Dr, Bezmialem Vakif University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sabahattin Destek, Principal Investigator, Clinical associate professor, Bezmialem Vakif University
    ClinicalTrials.gov Identifier:
    NCT04488640
    Other Study ID Numbers:
    • 8131643
    First Posted:
    Jul 28, 2020
    Last Update Posted:
    Jul 28, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sabahattin Destek, Principal Investigator, Clinical associate professor, Bezmialem Vakif University
    TI-RADS score
    Thyroid fine needle aspiration biopsy
    Thyroid core needle biopsy
    Surgical pathology
    Additional relevant MeSH terms:
    Thyroid Nodule
    Thyroid Diseases

    Study Results

    No Results Posted as of Jul 28, 2020