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

Sponsor
Assiut University
Study ID
NCT06984991
Status
Recruiting
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Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • fine needle aspiration — DIAGNOSTIC_TEST
    Different needle sizes will be used in FNA sampling ; 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 within the nodule in a single session. Samples will be primarily obtained without suction via the capillary method. However, aspiration with suction will be applied if no aspirates could be obtained in the needle hub after routine capillary method. For mixed cystic solid lesions; FNA will be done from the solid component after aspiration of the cystic component

Study Details

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.

Key Dates

First listed
May 22, 2025
Start date
Jun 1, 2025
Status verified
Jan 2026
Primary completion
Jul 1, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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 .

Primary Outcome Measure

rate of sample adequacy [ Time Frame: Day 1 ]

Central Contacts

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