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. 2021 Aug;9(8):E1269-E1275.
doi: 10.1055/a-1480-0428. Epub 2021 Jul 16.

Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study

Angels Ginès  1   2   3 , Pietro Fusaroli  4 , Oriol Sendino  1   2   3 , Andrada Seicean  5 , Antonio Z Gimeno-Garcia  6 , Jordi Gratacós-Ginès  1 , Isis K Araujo  1   3 , Leonardo Rodríguez-Carunchio  7 , Silvia Alós  7 , Andrea Lisotti  4 , Anna Cominardi  4 , Andrea Montenegro  1 , Glòria Fernández-Esparrach  1   2   3
Affiliations

Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study

Angels Ginès et al. Endosc Int Open. 2021 Aug.

Abstract

Background and study aims The poor flexibility of large-bore EUS needles often leads to technical failure when sampling from the duodenum. The aim of this study was to evaluate the technical and diagnostic performances of a new Menghini tip 19G nitinol EUS needle for sampling pancreatic solid lesions in the head and uncinate process. Patients and methods This was a European prospective multicenter single-arm study. A maximum of four passes were allowed. In case of failure, different needles were permitted. Results We included 75 patients (51 % males) with lesions in the head (n = 68; 91 %) and uncinate process (n = 7; 9 %) (mean size: 33 ± 12 mm; number of passes: 1.8 ± 0.9). Technical success was seen in 71 of 75 (94.7 %). Diagnostic rates were 89.3 % (67/75) and 94.4 % (67/71) in the intention-to-treat (ITT) and per-protocol (PP) analysis, respectively. In the eight cases with failure, diagnosis was obtained with another needle (n = 4), from another lesion (n = 3) or with follow-up (n = 1). A histological sample was obtained in 64 patients (ITT 85.3 % and PP 90 %) and immunohistochemistry was successfully performed in 13 of 15 lesions in which it was required. No differences between rapid on-site evaluation (ROSE) and non-ROSE groups were observed regarding diagnostic success (87.5 % vs 91 %, P = 0.582) and diagnosis at the first pass (70 % vs 81 %, P = 0.289). Number of passes was lower in the ROSE group (1.4 + 0.9 vs 2.2 + 0.7, P < 0.001). One adverse event was recorded (1.3 %) consisting in a duodenal perforation after a single session EUS-ERCP. Conclusions The new nitinol Menghini tip 19G EUS needle showed high technical diagnostic success in safely sampling solid lesions in the head and uncinate process of the pancreas.

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Conflict of interest statement

Competing interests Dr. Fernández-Esparrach has received fees for organizing courses for Norgine Iberia and Olympus Spain in the last 2 years and has been a consultant for trial design for CDx Diagnostics. Dr. Ginès has been a consultant for Cook Medical and Olympus Europe.

Figures

Fig. 1
Fig. 1
New nitinol 19 G needle with a multilayer coil sheath and a Menghini tip.
Fig. 2 a
Fig. 2 a
Cell block of a sample obtained by a 19 G EZ Shot 3 Plus needle showing biopsy cores (HE × 40). b Three biopsy cores that show stromal desmoplasia and infiltrating cells of adenocarcinoma (arrow) (HE × 100).
Fig. 3
Fig. 3
Flowchart showing the management of patients in whom the study needle failed.
See this image and copyright information in PMC

References

    1. Puli S R, Bechtold M L, Buxbaum J L et al.How good is endoscopic ultrasound-guided fine-needle aspiration in diagnosing the correct etiology for a solid pancreatic mass? A meta-analysis and systematic review. Pancreas. 2013;42:20–26. - PubMed
    1. Fusaroli P, Kypraios D, Eloubeidi M A et al.Levels of evidence in endoscopic ultrasonography: A systematic review. Digest Dis Sci. 2012;57:602–609. - PubMed
    1. Dumonceau J M, Deprez P H, Jenssen C A et al.Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline – Updated January 2017. Endoscopy. 2017;49:695–714. - PubMed
    1. Jenssen C, Hocke M, Fusaroli P et al.EFSUMB Guidelines on Interventional Ultrasound (INVUS), Part IV – EUS-guided interventions: General Aspects and EUS-guided Sampling (Short Version) Ultraschall in der Medizin. 2016;37:157–169. - PubMed
    1. Fusaroli P, Kypreos D, Alma Petrini C A et al.Scientific publications in endoscopic ultrasonography: Changing trends in the third millennium. J Clin Gastroenterol. 2011;45:400–404. - PubMed