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A7319 - Pre-Clinical Evaluations of 25G EBUS-TBNA Needles with and Without Side Ports
Author Block: S. Parthiban1, A. Tremblay2, D. Dillard1, H. Gonzalez1; 1Olympus Respiratory America, Redmond, WA, United States, 2Univ of Calgary, Calgary, AB, Canada.
Introduction: EBUS-TBNA is widely used for mediastinal lymph node staging. Some commercially available needles for these procedures include a side port. Comparisons done in clinical setting suggest that needles with side ports have improved diagnostic yield. However, in those studies the authors didn’t provide description of their control needles. Here we report the results of in-vivo animal evaluations performed to compare the sample collection of 25G needles with and without side ports. Methods: Two physicians experienced in EBUS-TBNA performed evaluations in three domestic swine using Procore (with side hole), Ultra (without side hole) 25G needles (Cook, USA) and prototype 25G needles with and without side holes (Olympus, Japan). In each animal, 4 suitable lymph nodes were sampled by physicians controlling for variables such as depth of penetration, number of passes and vacuum. The sequence of device use was randomized for the first lymph node and rotated in subsequent nodes. The first drops of the specimens were expelled on a flat slide for creating a smear and the rest of the sample was ejected into a well slide containing a small amount of saline. The samples were then rated qualitatively by the physician using a predefined scale. Quantitative sample size measurements were made by ImageJ analysis of the sample surface area. The smears were reviewed by an experienced cytotechnologist who was blinded. Results: A total of 64 samples were taken (4 needles, 16 samples per device). The average percentage of lymphocytes in the smears was 96.73 ± 3.64 %. Qualitatively, the prototype without side hole collected larger samples than the prototype with side hole. Both prototypes collected equivalent amount of samples when compared to the Cook Procore needle. The Cook Ultra needle collected the least amount of samples among the needles. There was no significant difference in tissue sample area between the prototypes (P > 0.8). Also, there was no significant difference in tissue sample area between the Cook Procore and prototype needles (P > 0.5). However, there was a marginally significant difference in sample tissue area between the Cook Procore and Ultra needles (P = 0.05). Conclusion: In this animal model, all 25G EBUS-TBNA needles evaluated collected cytological samples from lymph nodes. Quantitatively and qualitatively, a difference in sample collection between the prototypes with and without side port was not observed when variables were controlled. Well-designed clinical studies are necessary to confirm these results.