Accuracy of Ultrasound Elastastography in Thyroid Nodular Disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of elastography for thyroid cancer
Study Overview
Brief Summary
Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.
Detailed Description
Aims:
Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population.
Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA.
Patient selection:
Inclusion criteria:
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 yr.
- •Recruitment in Endocrinology surgery.
- •Nodular goiter.
- •Multinodular goiter with dominant nodule > 1 cm.
Exclusion Criteria
- •Toxic nodules
- •Non-accessible nodules to US or FNA
- •Cystic nodules
- •Nodules with calcifications in egg rind
- •Contraindication of FNA
Outcomes
Primary Outcomes
Diagnostic accuracy of elastography for thyroid cancer
Time Frame: 1 day
Sensitivity, specifity, predictive values
Secondary Outcomes
No secondary outcomes reported