Trials / Unknown
UnknownNCT04411290
Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Umraniye Education and Research Hospital · Other Government
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Thyroid Carcinoma
- Thyroid Papillary Carcinoma
- Multinodular Goiter, Adolescent
- Solitary Thyroid Nodule
- Thyroid Diseases
- Multifocal Dysplasia
- Aspiration
- Thyroid Nodule
- Thyroid Cancer, Papillary
- Thyroid Neoplasms
- Thyroid Goiter
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Total thyroidectomy (TT) | Final total thyroidectomy histopathology report should be available for correlations with preoperatively determined malignancy predictive factors, Bethesda (cytology) and TI-RADS (ultrasound findings) |
Timeline
- Start date
- 2020-05-15
- Primary completion
- 2021-06-01
- Completion
- 2021-06-01
- First posted
- 2020-06-02
- Last updated
- 2020-06-02
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04411290. Inclusion in this directory is not an endorsement.