Abstract
BackgroundFine needle aspiration biopsy (FNAB) cytology has been a highly effective methodology for tissue diagnosis and for various ancillary studies including molecular tests. In addition to other benefits, FNAB predominantly retrieves the diagnostic loosely cohesive cells in the lesion as compared to the adjacent supporting stroma with relatively higher cohesiveness. However, FNAB procedure performed with currently available resources is highly skill dependent with inter-performer variability, which compromises its full potential as a diagnostic tool. In this study we report a device overcoming these limitations.Methods'Tissue Harvester with Functional Valve' (THFV) was evaluated as part of a phase 1 National Institute of Health (NIH) research grant under Small Business Technology Transfer (STTR) Program. Working prototypes of the device were prepared. Each of the four cytopathologists with previous cytopathology fellowship training and experience in performing FNAB evaluated 5 THFV and 5 hypodermic needles resulting in 40 specimens (20 with THFV, 20 with hypodermic needles). A piece of fresh cattle liver stuffed in latex glove was used as the specimen. Based on these results a finished design was finalized.ResultsThe smears and cell blocks prepared from the specimens obtained by THFV were superior in terms of cellularity to specimens obtained with hypodermic needles. The tissuecrit of specimens obtained with THFV ranged from 70 to 100 μl (mean 87, SD 10), compared to 17 to 30 μl (mean 24, SD 4) with conventional hypodermic needles (p < .0001, Student t-test). The technical ease [on a scale of 1 (easy) to 5 (difficult)] with THFV ranged from 1 to 2 as compared to 2 to 3 with hypodermic needles.ConclusionThe specimen yield with the new THFV was significantly higher when compared to hypodermic needles. Also, the FNAB procedure with THFV was relatively easier in comparison with hypodermic needles. The final version of Shidham's THFV device would improve the FNAB specimen yield by eliminating the skill factor. The increased specimen yield by this device would also facilitate wider application of FNAB specimens for various ancillary tests, including molecular tests.
Highlights
Fine needle aspiration biopsy (FNAB) cytology has been a highly effective methodology for tissue diagnosis and for various ancillary studies including molecular tests
As part of a phase 1 National Institute of Health (NIH) research grant under Small Business Technology Transfer (STTR) Program, the novel design of THFV by authors VS and AS was evaluated by cytopathology fellowship trained cytopathologists [19]
Rapid prototypes (Figures 3 and 4) of THFV device were prepared by Stereolithography (SLA) after critical evaluation of three dimensional computer assisted design (CAD) using SolidWorks® software (SolidWorks Corporation, Concord, MA)
Summary
Fine needle aspiration biopsy (FNAB) cytology has been a highly effective methodology for tissue diagnosis and for various ancillary studies including molecular tests. Fine Needle Aspiration Biopsy (FNAB) is a safe, rapid, economical, and minimally invasive non-surgical technique for tissue diagnosis of various tumors and lesions [1,2,3,4,5,6,7,8,9,10,11,12,13,14,15] It is widely performed around the world including in more than six thousand hospitals in the United States [16,17]. One of the major limiting factors of a conventional hypodermic needle is the narrow diameter and low volume of the hub (Figure 1D) This restricts the quantity of specimen material that can accumulate in the hub at the end of the FNAB procedure without entering the syringe. These factors contribute to qualitatively and quantitatively poor diagnostic material with a higher proportion of unsatisfactory results
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