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; Pietro Fusaroli; Oriol Sendino; Andrada Seicean; Antonio Z. Gimeno-Garcia; Jordi Gratacós-Ginès; Isis K. Araujo; Leonardo Rodríguez-Carunchio; Silvia Alós; Andrea Lisotti; Anna Cominardi; Andrea Montenegro; Glòria Fernández-Esparrach

doi:10.1055/a-1480-0428

Endoscopy International Open, Table of Contents

CC BY-NC-ND 4.0 · Endosc Int Open 2021; 09(08): E1269-E1275
DOI: 10.1055/a-1480-0428

Original article

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

Authors

Angels Ginès

¹Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain

²CIBEREHD Barcelona, Spain

³IDIBAPS – Medicina, Barcelona, Spain
Pietro Fusaroli

⁴Hospital of Imola – GI Unit, University of Bologna, Imola, Italy
Oriol Sendino

¹Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain

²CIBEREHD Barcelona, Spain

³IDIBAPS – Medicina, Barcelona, Spain
Andrada Seicean

⁵University of Medicine and Pharmacy – Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania
Antonio Z. Gimeno-Garcia

⁶Hospital Universitario de de Sta Cruz de Tenerife – Service of Gastroenterology, Tenerife, Spain
Jordi Gratacós-Ginès

¹Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain
Isis K. Araujo

¹Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain

³IDIBAPS – Medicina, Barcelona, Spain
Leonardo Rodríguez-Carunchio

⁷Hospital Clinic de Barcelona – Pathology Department, University of Vic – Central University of Catalonia (UVic-UCC), Barcelona, Spain
Silvia Alós

⁷Hospital Clinic de Barcelona – Pathology Department, University of Vic – Central University of Catalonia (UVic-UCC), Barcelona, Spain
Andrea Lisotti

⁴Hospital of Imola – GI Unit, University of Bologna, Imola, Italy
Anna Cominardi

⁴Hospital of Imola – GI Unit, University of Bologna, Imola, Italy
Andrea Montenegro

¹Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain
Glòria Fernández-Esparrach

¹Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain

²CIBEREHD Barcelona, Spain

³IDIBAPS – Medicina, Barcelona, Spain

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.

Full Text

References

References
1 Puli SR, Bechtold ML, Buxbaum JL. 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
2 Fusaroli P, Kypraios D, Eloubeidi MA. et al. Levels of evidence in endoscopic ultrasonography: A systematic review. Digest Dis Sci 2012; 57: 602-609
3 Dumonceau JM, Deprez PH, Jenssen CA. 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
4 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
5 Fusaroli P, Kypreos D, Alma Petrini CA. et al. Scientific publications in endoscopic ultrasonography: Changing trends in the third millennium. J Clin Gastroenterol 2011; 45: 400-404
6 Polkowski M, Jenssen C, Kaye P. et al. Technical aspects of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline. Endoscopy 2017; 49: 989-1006
7 Bang JY, Hebert-Magee S, Ramesh J. et al. Randomized trial comparing the fanning with standard technique for endoscopic ultrasound-guided fine needle aspiration of solid pancreatic mass lesions. Endoscopy 2013; 45: 445-450
8 Varadarajulu S, Fraig M, Schmulewitz N. et al. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy 2004; 36: 397-401
9 Fernández-Esparrach G, Sendino O, Solé M. et al. EUS-guided trucut biopsy in the diagnosis of gastric stromal tumors: a randomized crossover study. Endoscopy 2010; 42: 292-299
10 Kong F, Zhu J, Kong X. et al. Rapid on-site evaluation does not improve endoscopic ultrasound-guided fine needle aspiration adequacy in pancreatic masses: a meta-analysis and systematic review. PLoS One 2016; 11: e0163056
11 Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I. et al. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol 2011; 106: 1705-1710
12 Wani S, Mullady D, Early DS. et al. The clinical impact of immediate onsite cytopathology evaluation during endoscopic ultrasound-guided fine needle aspiration of pancreatic masses: a prospective multicenter randomized controlled trial. Am J Gastroenterol 2015; 110: 1429-1439
13 Lee LS, Nieto J, Watson RR. et al. Randomized noninferiority trial comparing diagnostic yield of cytopathologist-guided versus 7 passes for EUS-FNA of pancreatic masses. Dig Endosc 2015; 28: 469-475
14 Hebert-Magee S, Bae S, Varadarajulu S. et al. The presence of a cytopathologist increases the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration cytology for pancreatic adenocarcinoma: a meta-analysis. Cytopathology 2013; 24: 159-171
15 Matynia AP, Schmidt RL, Barraza G. et al. Impact of rapid on-site evaluation on the adequacy of endoscopic-ultrasound guided fine-needle aspiration of solid pancreatic lesions: a systematic review and meta-analysis. J Gastroenterol Hepatol 2014; 29: 697-705
16 Ginès A. Novel design fine-needle biopsy needles are ready to take over the supremacy of fine-needle aspiration needles for sampling of solid pancreatic masses. Endoscopy 2020; 52: 427-428
17 Song TJ, Kim JH, Lee SS. et al. The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22 G and 19 G aspiration needles for solid pancreatic or peripancreatic masses. Am J Gastroenterol 2010; 105: 1739-1745
18 Itoi T, Itokawa F, Sofuni A. et al. Evaluation of 19-gauge endoscopic ultrasonography aspiration needles using various echoendoscopes. Endosc Int Open 2013; 1: E24-E30
19 Tang S-J, Vilmann AS, Saftoiu A. et al. EUS Needle Identification Comparison and Evaluation study (with videos). Gastrointest Endosc 2016; 84: 424-433.e2
20 Laquière A, Lefort C, Maire F. et al. 19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study. Endoscopy 2019; 51: 436-443
21 Varadarajulu S, Bang JY, Hebert-Magee S. Assessment of the technical performance of the flexible 19-gauge EUS-FNA needle. Gastrointest Endosc 2012; 76: 336-343
22 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
23 Fleiss JL, Levin B, Paik MC. Statistical Methods for Rates and Proportions. 3rd ed. New York: John Wiley & Sons; 2003
24 Adler DG, Witt B, Chadwick B. et al. Pathologic evaluation of a new endoscopic ultrasound needle designed to obtain core tissue samples: A pilot study. Endosc Ultrasound 2016; 5: 178-183
25 Nayar MK, Paranandi B, Dawwas MF. et al. Comparison of the diagnostic performance of 2 core biopsy needles for EUS-guided tissue acquisition from solid pancreatic lesions. Gastrointest Endosc 2017; 85: 1017-1024
26 Alatawi A, Beuvon F, Grabar S. et al. Comparison of 22G reverse beveled versus standard needle for endoscopic ultrasound-guided sampling of solid pancreatic lesions. United European Gastroenterol J 2015; 3: 343-352
27 Park SW, Chung MJ, Lee SH. et al. Prospective study for comparison of endoscopic ultrasound-guided tissue acquisition using 25- and 22- gauge core biopsy needles in solid pancreatic masses. PLoS One 2016; 11: e0154401
28 Larghi A, Iglesias-Garcia J, Poley JW. et al. Feasibility and yield of a novel 22-gauge histology EUS needle in patients with pancreatic masses: a multicenter prospective cohort study. Surg Endosc 2013; 27: 3733-3738
29 Hewitt MJ, McPhail MJ, Possamai L. et al. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc 2012; 75: 319-331