A Preclinical Evaluation Comparing the Performance of a Novel 19-G Flexible Needle to a Commercially Available 22-G EBUS-TBNA Sampling Needle

Abstract

Background: Needle samples may not provide sufficient diagnostic material for the assessment of mediastinal lymph nodes. Objective: The study compared the specimen size and diagnostic performance of a new 19-G endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) needle to that of a standard 22-G EBUS-TBNA needle in a swine model of granulomatous lymphadenopathy. Methods: Granulomatous inflammation was induced in mediastinal lymph nodes (LNs) of 10 domestic swine by injection oftalc slurry. The affected LNs were sampled with the 19- and 22-G needles. Collected core tissue area and volume were determined using a specialized software and known needle internal diameter. The sample's quality was assessed using the biopsy core morphology grade (BCMG) as well as the biopsy diagnostic correlation grade (BDCG). Results: There was a significant increase in the average LN size from baseline (11.6 ± 3.2 to 15.2 ± 3.8 mm; p < 0.001) after talc injection. A total of 132 paired samples were collected from 38 LNs. The average mass and volume of the 19-G needle sample were larger than those of the 22-G needle sample: 33.78 ± 47.48 vs. 25.18 ± 32.08 mg (p < 0.002) and 11.40 ± 13.91 vs. 6.91 ± 6.42 mm³ (p < 0.0004), respectively. The pooled needle biopsy samples for the 19- and the 22-G needles had similar BCMG (1.38 ± 0.86 vs. 1.43 ± 0.87, p > 0.2) and BDCG (1.54 ± 0.93 vs. 1.57 ± 0.93, p > 0.2). The 19-G needle samples tended towards less blood contamination (p = 0.057), more often granuloma identification (46 vs. 32%, p = 0.2) and had more cartilage contamination (0.49 ± 1.46 vs. 4.81 ± 16.49% p < 0.003). Conclusion: In experienced hands, the 19- and the 22-G EBUS-TBNA needles have a similar diagnostic yield in the swine model of granulomatous lymphadenopathy. The samples collected by the 19-G needle are larger and may have less blood contamination.

Comparing the Clinical Performance of the New 19-G ViziShot FLEX and 21- or 22-G ViziShot 2 Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Needles

“…In a preclinical evaluation comparing a novel 19-G flexible needle with a commercial 22-G EBUS-TBNA sampling needle, the samples collected with the 19-G needle were larger and had less blood contamination than those obtained with a 22-G needle (15). In our study, the use of the 19-G needle also provided sufficient tissue samples with less blood contamination that proved useful for diagnosing retinal hemangioblastoma, lung adenocarcinoma, and tuberculous lymphadenitis and for evaluating the PD-L1 expression in specimens whose findings had initially been negative with a 21- or 22-G needle.…”

A Randomized Clinical Trial of Flex 19G Needles versus 22G Needles for Endobronchial Ultrasonography in Suspected Lung Cancer

“…Recent advances in needle development resulted in a flexible 19G (Flex 19 G) needle with an inner diameter of 0.69 mm. In a preclinical swine model of granulomatous lymphadenopathy, the Flex 19G and 22G EBUS-TBNA needles had a similar diagnostic yield, but the Flex 19G needle samples were larger [9].…”

A Randomized Trial Evaluating the Effect of 10 versus 20 Revolutions Inside the Lymph Node on the Diagnostic Yield of EBUS-TBNA in Subjects with Sarcoidosis

“…In studies performed in general populations of subjects with mediastinal lymphadenopathy (not specifically sarcoidosis) undergoing EBUS-TBNA, it has been demonstrated that the use of either suction or the stylet provided with the EBUS-TBNA needle does not affect the diagnostic yield [16,29]. The use of a novel flexible 19G needle has also been investigated in preliminary studies [30,31]. Before the present study, there was no report on the effect of the number of revolutions performed inside the lymph node on the diagnostic yield.…”