Management of Indeterminate Thyroid Nodules Across Different World Regions

Study Overview
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Brief Summary
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Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Fine needle aspiration cytology (FNAC) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. Nevertheless, FNAC is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class III and class IV according to Bethesda Classification[2]). In fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. Thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems. We aim to evaluate different approaches to indeterminate nodules across different countries in the world.

Official Title
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Management of Indeterminate Thyroid Nodules Across Different World Regions: a Multicentric International Study

Conditions
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Indeterminate Thyroid Nodules

Intervention / Treatment
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* Procedure: Thyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Bethesda III / Bethesda IV thyroid nodules Exclusion Criteria: Patients with preoperative diagnosis of lymph node metastases
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| South East Asian Region (SEAR)<br>Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR | Procedure: Thyroidectomy<br>* Total thyroidectomy or lobectomy<br>|
| Americas Region (AMR)<br>Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR | Procedure: Thyroidectomy<br>* Total thyroidectomy or lobectomy<br>|
| Eastern Mediterranean Region (EMR)<br>Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR | Procedure: Thyroidectomy<br>* Total thyroidectomy or lobectomy<br>|
| the Europe Region (EUR)<br>Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR | Procedure: Thyroidectomy<br>* Total thyroidectomy or lobectomy<br>|
| Western Pacific Region (WPR)<br>Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR | Procedure: Thyroidectomy<br>* Total thyroidectomy or lobectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of malignancy | Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules | 36 months | 
| Surgical approach to indeterminate thyroid nodules | Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid carcinoma, Indeterminate thyroid nodule