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CC BY-NC-ND 4.0 · Endosc Int Open 2024; 12(04): E467-E473
DOI: 10.1055/a-2236-7654
Original article

Establishing the optimal number of passes during EUS-FNB for diagnosis of pancreatic solid lesions: Prospective multicenter study

Benedetto Mangiavillano 
1   Gastrointestinal Endoscopy, Istituto Clinico Mater Domini Casa di Cura Privata SpA, Castellanza, Italy (Ringgold ID: RIN9348)
,
Antonio Facciorusso 
2   Medical Sciences, Gastroenterology, Foggia, Italy
,
Francesco Maria Di Matteo
3   Operative Endoscopy Department, Campus Bio-Medico University Hospital, Roma, Italy (Ringgold ID: RIN220431)
,
Carmelo Barbera
4   Gastroenterology and Digestive Endoscopy Unit, Nuovo Ospedale Civile S. Agostino-Estense, Baggiovara di Modena (Mo), Italy
5   Gastroenterology and Digestive Endoscopy Unit, Azienda Unita Sanitaria Locale di Modena, Italy (Ringgold ID: RIN18067)
,
Alberto Larghi
6   Digestive Endoscopy Unit, Universita' Cattolica del Sacro Cuore, Rome, Italy
,
Gianenrico Rizzatti
7   Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
,
Silvia Carrara
8   Digestive Endoscopy, Istituto Clinico Humanitas, Rozzano, Italy
,
Andrea Lisotti 
9   Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola, Italy (Ringgold ID: RIN9296)
,
Pietro Fusaroli 
10   Gastroenterology Unit, University of Bologna, Imola, Italy
,
Luca De Luca 
11   Gastroenterology and Digestive Endoscopy, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy (Ringgold ID: RIN18635)
,
Milena Di Leo
12   Division of Gastroenterology, Digestive Endoscopy Unit, Rozzano (Milan), Italy
13   Department of Biomedical Science, Humanitas University, Milan, Italy (Ringgold ID: RIN437807)
,
Maria Cristina Conti Bellocchi
14   Gastroenterology and Digestive Endoscopy Unit, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy (Ringgold ID: RIN9286)
,
Marco Spadaccini 
15   Digestive Endoscopy Unit, Division of Gastroenterology, Istituto Clinico Humanitas, Rozzano, Italy (Ringgold ID: RIN9268)
,
Emanuele Dabizzi
16   Digestive Endoscopy, Nuovo Ospedale Civile S. Agostino Estense di Baggiovara, Modena, Modena, Italy
,
Francesco Auriemma
17   Gastroenterologia, Università Federico II, Napoli, Italy
15   Digestive Endoscopy Unit, Division of Gastroenterology, Istituto Clinico Humanitas, Rozzano, Italy (Ringgold ID: RIN9268)
,
Serena Stigliano
18   Operative Endoscopy Department, Campus Bio-Medico University, Roma, Italy (Ringgold ID: RIN9317)
,
Daryl Ramai
19   Gastroenterology and Hepatology, The University of Utah School of Medicine, Salt Lake City, United States (Ringgold ID: RIN12348)
,
Federica Calabrese
20   Gastrointestinal Endoscopy, Istituto Clinico Mater Domini Casa di Cura Privata SpA, Castellanza, Varese, Italy (Ringgold ID: RIN9348)
,
Erminia Manfrin
21   Department of Diagnostics and Public Health, University of Verona Hospital Trust P.Le L.A. Scuro 10, Verona, Italy
,
Danilo Paduano
22   Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza, Italy
,
Cesare Hassan 
23   Department of Biomedical Sciences, Humanitas University, Milan, Italy (Ringgold ID: RIN437807)
24   Endoscopy Unit, IRCCS Humanitas Clinical and Research Center, Milan, Italy
,
Alessandro Repici
25   Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy (Ringgold ID: RIN437807)
26   Digestive Endoscopy Unit, IRCCS Humanitas Research Hospital, Rozzano, Italy (Ringgold ID: RIN9268)
,
Stefano Francesco Crinó 
27   Gastroenterology and Digestive Endoscopy Unit, Pancreas Institute, University of Verona, Verona, Italy (Ringgold ID: RIN19051)
› Author Affiliations Clinical Trial: Registration number (trial ID): NCT05436704, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective, longitudinal
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Abstract

Background and study aims The optimal number of needle passes during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) is not yet established. We aimed to perform a per-pass analysis of the diagnostic accuracy of EUS-FNB of solid pancreatic lesions using a 22G Franseen needle.

Patients and methods Consecutive patients with solid pancreatic lesions referred to 11 Italian centers were prospectively enrolled. Three needle passes were performed; specimens were collected after each pass and processed individually as standard histology following macroscopic on-site evaluation (MOSE) by the endoscopist. The primary endpoint was diagnostic accuracy of each sequential pass. Final diagnosis was established based on surgical pathology or a clinical course of at least 6 months. Secondary endpoints were specimen adequacy, MOSE reliability, factors impacting diagnostic accuracy, and procedure-related adverse events.

Results A total of 504 samples from 168 patients were evaluated. Diagnostic accuracy was 90.5% (85.0%–94.1%) after one pass and 97.6% (94.1%–99.3%) after two passes (P=0.01). Similarly, diagnostic sensitivity and sample adequacy were significantly higher adding the second needle pass (90.2%, 84.6%–94.3% vs 97.5%, 93.8%–99.3%, P=0.009 and 91.1%, 85.7%-94.9% vs 98.2%, 95.8%–99.3%, P=0.009, one pass vs two passes, respectively). Accuracy, sensitivity, and adequacy remained the same after the third pass. The concordance between MOSE and histological evaluation was 89.9%. The number of passes was the only factor associated with accuracy. One case of mild acute pancreatitis (0.6%) was managed conservatively.

Conclusions At least two passes should be performed for the diagnosis of solid pancreatic lesions. MOSE is a reliable tool to predict the histological adequacy of specimens.

Keywords

Pancreas - Endoscopic ultrasonography - Fine-needle aspiration/biopsy


Publication History

Received: 28 November 2023

Accepted after revision: 19 December 2023

Accepted Manuscript online:
02 January 2024

Article published online:
05 April 2024

© 2024. 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/).

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