Factors Influencing Inadequacy in Rapid Onsite Evaluation of Ultrasound Guided Fine Needle Aspiration (FNA) Samples of Thyroid Nodules

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Thyroid nodules are a common clinical finding with a prevalence of around 50-67% in the general population using ultrasound examinations. Of these, malignancies account for 5-15% including the treatable papillary and follicular thyroid carcinomas and the rarer but more aggressive medullary and undifferentiated thyroid cancers. Fine Needle Aspiration (FNA) is a relatively simple, cost-effective recommended standard diagnostic procedure with high sensitivity and specificity for the preoperative evaluation of benign and malignant thyroid nodules. Cytopathology reports of thyroid FNA are categorized using a universal grading system, which helps to standardize reporting of diagnostic thyroid cytology results. In the non-diagnostic/unsatisfactory category (Bethesda I), ranging from 1% to 20% of samples, pathologists are unable to make a clinical diagnosis based on these samples due to an inadequate number of cells or difficulty in identifying cells. The estimated risk of malignancy in this category is 1-4 %, which usually managed by repeating FNA with increase in patient discomfort, procedural complications and medical costs. There are few other prospective studies investigated the effect of needle size, and sampling technique on sample adequacy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients referred for FNA of thyroid nodules (TIRAD-3, 4 and 5 nodules).

Locations
Other Locations
Egypt
Assiut University Hospital
RECRUITING
Asyut
Contact Information
Primary
Ramy M Mohammed, MD of radiology
ramycolor@aun.edu.eg
+201153070865
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 160
Treatments
Experimental: thyroid FNA
All FNAs will be performed by experienced radiologists (of 5-year experience in thyroid FNA procedures). Patients will be positioned comfortably, typically in a supine position with neck extension after putting a pillow under shoulders to fully expose the patient's neck to allow optimal access to the nodule. Ultrasound guidance using Logic E9 machine (GE Healthcare, Chicago, IL, USA) or Sonoscape X5 Portable Ultrasound machine with high-frequency linear array probes (3-12 MHz) will be used to visualize the nodule accurately and guide needle placement. 5ml syringe with 21G needle, 3ml syringe with 23G needle or 22G Quincke tip spinal needle will be used for FNA. Needle insertion will be directed either trans-isthmic or lateral cervical approach. Aspirations will be conducted at different angles and within different nodule regions using a to-and-fro motion till getting blood stain in the needle hub to obtain representative samples. Maximum number of four passes will be performed .
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov