Management of Indeterminate Thyroid Nodules Across Different World Regions
- Conditions
- Indeterminate Thyroid Nodules
- Interventions
- Procedure: Thyroidectomy
- Registration Number
- NCT05851404
- Lead Sponsor
- University of Cagliari
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- Patients with Bethesda III / Bethesda IV thyroid nodules
- Patients with preoperative diagnosis of lymph node metastases
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description South East Asian Region (SEAR) Thyroidectomy Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR Americas Region (AMR) Thyroidectomy Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR Eastern Mediterranean Region (EMR) Thyroidectomy Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR the Europe Region (EUR) Thyroidectomy Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR Western Pacific Region (WPR) Thyroidectomy Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR
- Primary Outcome Measures
Name Time Method Rate of malignancy 36 months Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules
Surgical approach to indeterminate thyroid nodules 36 months Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AOU Cagliari
🇮🇹Cagliari, CA, Italy