Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study
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 lesion...
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Georg Thieme Verlag KG
2021-07-01
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doaj-d853c239457a4e618956eb70e252ec692021-08-24T08:40:29ZengGeorg Thieme Verlag KGEndoscopy International Open2364-37222196-97362021-07-010908E1269E127510.1055/a-1480-0428Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter studyAngels Ginès0Pietro Fusaroli1Oriol Sendino2Andrada Seicean3Antonio Z. Gimeno-Garcia4Jordi Gratacós-Ginès5Isis K. Araujo6Leonardo Rodríguez-Carunchio7Silvia Alós8Andrea Lisotti9Anna Cominardi10Andrea Montenegro11Glòria Fernández-Esparrach12Hospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, SpainHospital of Imola – GI Unit, University of Bologna, Imola, ItalyHospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, SpainUniversity of Medicine and Pharmacy – Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, RomaniaHospital Universitario de de Sta Cruz de Tenerife – Service of Gastroenterology, Tenerife, SpainHospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, SpainHospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, SpainHospital Clinic de Barcelona – Pathology Department, University of Vic – Central University of Catalonia (UVic-UCC), Barcelona, SpainHospital Clinic de Barcelona – Pathology Department, University of Vic – Central University of Catalonia (UVic-UCC), Barcelona, SpainHospital of Imola – GI Unit, University of Bologna, Imola, ItalyHospital of Imola – GI Unit, University of Bologna, Imola, ItalyHospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, SpainHospital Clinic de Barcelona – Endoscopy Unit, Barcelona. University of Barcelona, SpainBackground 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.http://www.thieme-connect.de/DOI/DOI?10.1055/a-1480-0428 |
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language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study Endoscopy International Open |
author_facet |
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 |
author_sort |
Angels Ginès |
title |
Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study |
title_short |
Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study |
title_full |
Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study |
title_fullStr |
Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study |
title_full_unstemmed |
Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study |
title_sort |
performance of a new flexible 19 g eus needle in pancreatic solid lesions located in the head and uncinate process: a prospective multicenter study |
publisher |
Georg Thieme Verlag KG |
series |
Endoscopy International Open |
issn |
2364-3722 2196-9736 |
publishDate |
2021-07-01 |
description |
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. |
url |
http://www.thieme-connect.de/DOI/DOI?10.1055/a-1480-0428 |
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