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

Condition(s) studied

Investigational drug(s) / intervention(s)

fine needle aspiration: 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 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

Primary outcome measure(s)

• rate of sample adequacy — Day 1
  Aspirated material will be expelled onto glass slides, which will be immediately fixed and stained for cytological analysis. Rapid On-Site Evaluation (ROSE) will be utilized to assess the sample adequacy during the procedure using the diff-quik (air-dried) slides, allowing for additional passes if necessary. In this situation, ROSE is not used for bedside diagnosis. An experienced pathologist reported the ical diagnosis/reporfinal cytologt only once the entire case (i.e. all of the slides) are reviewed according to the Bethesda criteria.: (I) nondiagnostic (ND) (fewer than six groups of well-visualized follicular cells, each group containing less than 10 well-preserved epithelial cells); (II) benign lesion; (III) atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS); (IV) follicular neoplasm/suspicious for follicular neoplasm (FN/SFN); (V) suspicious for malignancy; and (VI) malignancy.

Trial sites (1)

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