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Flow Diagram of the Outcome of ThyroSeq Testing
286 Surgeon-Performed US-Guided FNAC Patients with Bethesda III or IV
26 Patients Elected ThyroSeq (as opposed to Diagnostic Surgery or Repeat FNAC)
that the needle tip was within the selected nodule by ultrasound guidance in all
cases. An immediate cytopathological
yield was determined. Cytology that immediately repeated with additional passes until adequacy for diagnosis diagnostic thyroid surgery, or molecular offered the option of diagnostic thyroid surgery or molecular testing per ATA guidelines.7 Patients were advised of and about the possible uncertainties in
the therapeutic and long-term clinical implications of results per ATA guidelines.7
one additional pass was obtained with ultrasound guidance and placed in
the nucleic acid preservative solution provided by the company (CBL Path)
for ThyroSeq testing. Overnight mail was used to ship the sample to CBL Path laboratory for analysis.
Patients with no mutation on ThyroSeq testing were offered active surveillance, with no mutation on ThyroSeq testing electing active surveillance are followed every six to 12 months with surgeon- performed ultrasound and surveyed for change of size of the nodules, change in ultrasound characteristics of nodules, or development of suspicious cervical lymph nodes. Patients with a mutation were recommended surgery.
16 Mutation -
16/16 Patients Elected Active Surveillance (as opposed to Diagnostic Surgery or Repeat FNAC)
FIGURE 2
9 Mutation +
1 No result
Surgery
1FVPTC
Surgery
2 PTC
2 FVPTC
5 Benign
Flow diagram of the outcome of ThyroSeq testing: US = Ultrasound; FNAC = fine-needle aspiration cytology; PTC=papillary thyroid cancer; FVPTC= follicular variant of papillary thyroid cancer.
The hypothesis of this study is that patients will elect molecular testing over diagnostic thyroid surgery for indeterminate thyroid nodules and ThyroSeq in a non-industry sponsored, real-world thyroid surgical practice with calculated cancer prevalence for indeterminate thyroid nodules (Bethesda III and IV) could reduce diagnostic thyroid surgery when there is no mutation.
METHODS
Christiana Care Institutional Review Board (IRB) approval was obtained
for this study. ATA guidelines7 were used for patient selection for surgeon performed, ultrasound guided thyroid Excluded from the series were patients
with a family or personal history of thyroid cancer, prior radiation therapy to the neck, compressive symptoms, nodules cervical lymphadenopathy and high-risk irregular contour, taller than wide shape,
of soft tissue component or evidence of extrathyroidal extension).7 Patient’s status of surgery or clinical observation was
A highly experienced cytopathologist
was present for on-site staining (Diff Quick) adequacy evaluation and molecular testing triage. This was followed by Pap Stain, Cell Block, and Thin Prep tests. A transverse ultrasound guided technique using a 27-guage needle was used in
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Del Med J | December 2016 | Vol. 88 | No. 12
