Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases

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Brief Title

Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases

Official Title

Correlation of Malignancy Predictors, Bethesda (I-VI) and TI-RADS Scores (I-V) With Final Histopathology in Patients Undergoing Total Thyroidectomy 34 Years After Chernobyl Disaster: Multi-centric Trial

Brief Summary

      In the last decades, thyroid cancer incidence has continuously increased all over the world,
      almost exclusively due to a sharp rise in the incidence of the papillary histologic subtype,
      which has the highest incidence of multifocality. Furthermore, Black Sea and Eastern European
      regions are both endemic and known to have been under the influence of Chernobyl nuclear
      explosion. Although overscreening might have a role in certain parts of the world, the
      predictors of malignancy such as family history, genetical disorders, previous radiation
      exposure, low iodine intake, diabetes and obesity, should also be taken into consideration in
      determining the extent of surgery.
    

Detailed Description

      High-frequency ultrasound (US) is increasingly used to help distinguish malignancy in
      patients with solitary or multiple nodules, and US-guided fine needle aspiration (FNA) has
      become the gold standard test for detecting thyroid cancer. Moreover, a further US-based risk
      stratification of thyroid nodules with Thyroid Imaging Reporting and Data System (TI-RADS)
      has been currently proposed for better and easier decision making. However, the presence of
      multiple nodules in the thyroid gland may decrease the diagnostic value of these preoperative
      diagnostic tools. The prevalence of incidental carcinoma identified on the final histological
      examination of the patients who underwent surgery for presumably benign thyroid diseases was
      previously reported to be roughly around 5 to 10%. Most of the previous studies also showed a
      lower risk of carcinoma in multinodular goitre (MNG) compared to solitary thyroid nodule
      (STN). However, some recent surgical series have reported that the risk of thyroid carcinoma
      in benign thyroid diseases is significantly higher than previously reported.

      The purpose of the present study is to detect the accuracy of preoperative cytology and
      US-findings (TI-RADS) and the prevalence of thyroid carcinoma in patients operated for
      thyroid diseases and to discuss all malignancy risk factors in detail along with final
      histopathological report. Cytology-histology discrepant cases will also be further evaluated
      for sampling and interpretation errors, and possible solutions to increase the accuracy of
      preop testing are going to be proposed. The accuracy of the preference of total thyroidectomy
      procedure will be evaluated considering the prevalence of incidental carcinomas diagnosed
      postoperatively, and whether there are variations in the risk of malignancy with respect to
      final pathology of patients will also be discussed in detail.
    


Study Type

Observational


Primary Outcome

Preoperative Evaluation of Malignancy Risk Factors-How many risk factors are present?


Condition

Thyroid Carcinoma

Intervention

Total thyroidectomy (TT)

Study Arms / Comparison Groups

 Total Thyroidectomy (TT)-indicated patients
Description:  Patients with presumably benign thyroid disease (multinodular goitre, solitary thyroid nodule, toxic goitre, etc.) Patients with thyroid carcinoma (biopsy-proved) Total thyroidectomy preference by the primary surgeon

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

200

Start Date

May 15, 2020

Completion Date

June 1, 2021

Primary Completion Date

June 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  >17 years all patients with benign/malign thyroid disease, total thyroidectomy is
             indicated/preferred by both primary surgeon and patient (signed informed consent is a
             must)

          -  All patients should have a malignancy predictive factors forms filled in

          -  All patients should have fine needle aspiration cytology (Bethesda category) available

          -  All patients should have an ultrasound evaluated according to TI-RADS

          -  All patients should have a final histopathology report

        Exclusion Criteria:

          -  Patients who are prepared for thyroid surgery other than total thyroidectomy procedure

          -  Age<17 years
      

Gender

All

Ages

17 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ethem UNAL, MD, PhD, , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT04411290

Organization ID

B.10.1.TKH.4.34.H.GP.0.01/172


Responsible Party

Principal Investigator

Study Sponsor

Umraniye Education and Research Hospital


Study Sponsor

Ethem UNAL, MD, PhD, Study Chair, Assoc. Professor of General Surgery and Surgical Oncology


Verification Date

May 2020