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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

Angels Ginès
1   Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain
2   CIBEREHD Barcelona, Spain
3   IDIBAPS – Medicina, Barcelona, Spain
,
Pietro Fusaroli
4   Hospital of Imola – GI Unit, University of Bologna, Imola, Italy
,
Oriol Sendino
1   Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain
2   CIBEREHD Barcelona, Spain
3   IDIBAPS – Medicina, Barcelona, Spain
,
Andrada Seicean
5   University of Medicine and Pharmacy – Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania
,
Antonio Z. Gimeno-Garcia
6   Hospital Universitario de de Sta Cruz de Tenerife – Service of Gastroenterology, Tenerife, Spain
,
Jordi Gratacós-Ginès
1   Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain
,
Isis K. Araujo
1   Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain
3   IDIBAPS – Medicina, Barcelona, Spain
,
Leonardo Rodríguez-Carunchio
7   Hospital Clinic de Barcelona – Pathology Department, University of Vic – Central University of Catalonia (UVic-UCC), Barcelona, Spain
,
Silvia Alós
7   Hospital Clinic de Barcelona – Pathology Department, University of Vic – Central University of Catalonia (UVic-UCC), Barcelona, Spain
,
Andrea Lisotti
4   Hospital of Imola – GI Unit, University of Bologna, Imola, Italy
,
Anna Cominardi
4   Hospital of Imola – GI Unit, University of Bologna, Imola, Italy
,
Andrea Montenegro
1   Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain
,
Glòria Fernández-Esparrach
1   Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, Spain
2   CIBEREHD Barcelona, Spain
3   IDIBAPS – Medicina, Barcelona, Spain
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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.



Publication History

Received: 23 January 2021

Accepted: 22 March 2021

Article published online:
16 July 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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