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©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Intraprocedural gastric juice analysis as compared to rapid urease test for real-time detection of Helicobacter pylori
Riccardo Vasapolli, Florent Ailloud, Sebastian Suerbaum, Jens Neumann, Nadine Koch, Lukas Macke, Jörg Schirra, Julia Mayerle, Peter Malfertheiner, Christian Schulz
Riccardo Vasapolli, Nadine Koch, Lukas Macke, Jörg Schirra, Julia Mayerle, Peter Malfertheiner, Christian Schulz, Medical Department ІІ, University Hospital LMU Munich, Munich 81377, Germany
Riccardo Vasapolli, Sebastian Suerbaum, Lukas Macke, Christian Schulz, Deutsches Zentrum für Infektionsforschung, Partner Site Munich, Munich 81377, Germany
Florent Ailloud, Sebastian Suerbaum, Max von Pettenkofer Institute, Faculty of Medicine, Ludwig-Maximilians University of Munich, Munich 80336, Germany
Florent Ailloud, Sebastian Suerbaum, National Reference Center for Helicobacter pylori, Munich 81377, Germany
Jens Neumann, Institute of Pathology, Faculty of Medicine, Ludwig-Maximilians-University of Munich, Munich 81377, Germany
Author contributions: Vasapolli R, Schulz C, and Malfertheiner P designed the study, interpreted the data and drafted the manuscript; Vasapolli R, Suerbaum S, Schirra J, Mayerle J, Schulz C, and Malfertheiner P obtained funding and supervised the study procedures; Vasapolli R recruited suitable subjects, performed endoscopy, and collected samples; Vasapolli R, Macke L, Ailloud F, and Koch N registered data and performed statistical analyses; Neumann J performed the histological analysis; All authors read and approved the final version of the manuscript.
Supported by the Deutsches Zentrum für Infektionsforschung, Partner Site Munich, Germany, No. TTU 06.715_00; and the Bavarian Ministry of Science and the Arts within the framework of the Bavarian Research Network “New Strategies Against Multi-Resistant Pathogens by Means of Digital Networking – bayresq.net”.
Institutional review board statement: This study was approved by the local ethics committee and government authorities and was conducted in accordance with current Good Clinical Practice guidelines and the Declaration of Helsinki. All recruited subjects provided written informed consent for participation.
Informed consent statement: Written informed consent was obtained from the participants.
Conflict-of-interest statement: The authors have nothing to disclose.
Data sharing statement: Data and analytic methods can be made available to other researchers upon request.
STROBE statement: The authors have read the STROBE statement, and the manuscript was prepared and revised according to the STROBE statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Christian Schulz, MD, Deputy Director, Medical Department ІІ, University Hospital LMU Munich, Marchionini Strasse 15, Munich 81377, Germany. chr.schulz@med.uni-muenchen.de
Received: November 19, 2022
Peer-review started: November 19, 2022
First decision: December 10, 2022
Revised: January 15, 2023
Accepted: February 22, 2023
Article in press: February 22, 2023
Published online: March 14, 2023
Processing time: 110 Days and 21.4 Hours
BACKGROUND
Endofaster is an innovative technology that can be combined with upper gastrointestinal endoscopy (UGE) to perform gastric juice analysis and real-time detection of Helicobacter pylori (H. pylori).
AIM
To assess the diagnostic performance of this technology and its impact on the management of H. pylori in the real-life clinical setting.
METHODS
Patients undergoing routine UGE were prospectively recruited. Biopsies were taken to assess gastric histology according to the updated Sydney system and for rapid urease test (RUT). Gastric juice sampling and analysis was performed using the Endofaster, and the diagnosis of H. pylori was based on real-time ammonium measurements. Histological detection of H. pylori served as the diagnostic gold standard for comparing Endofaster-based H. pylori diagnosis with RUT-based H. pylori detection.
RESULTS
A total of 198 patients were prospectively enrolled in an H. pylori diagnostic study by Endofaster-based gastric juice analysis (EGJA) during the UGE. Biopsies for RUT and histological assessment were performed on 161 patients (82 men and 79 women, mean age 54.8 ± 19.2 years). H. pylori infection was detected by histology in 47 (29.2%) patients. Overall, the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value (NPV) for H. pylori diagnosis by EGJA were 91.5%, 93.0%, 92.6%, 84.3%, and 96.4%, respectively. In patients on treatment with proton pump inhibitors, diagnostic sensitivity was reduced by 27.3%, while specificity and NPV were unaffected. EGJA and RUT were comparable in diagnostic performance and highly concordant in H. pylori detection (κ-value = 0.85).
CONCLUSION
Endofaster allows for rapid and highly accurate detection of H. pylori during gastroscopy. This may guide taking additional biopsies for antibiotic susceptibility testing during the same procedure and then selecting an individually tailored eradication regimen.
Core Tip: Diagnosis of Helicobacter pylori (H. pylori) infection can be rapidly achieved within the framework of gastroscopy by rapid urease test (RUT) or by gastric juice analysis with Endofaster. In this prospective observational study, we compared the accuracy of these two methods. Gastric juice analysis with Endofaster could reliably detect H. pylori with high accuracy, showing a diagnostic performance comparable to that of RUT and a major advantage of an immediate result. Intraprocedural H. pylori detection (or exclusion) is crucial to optimize the diagnostic approach and improve the management of infection. The diagnosis of Endofaster may guide additional sampling for antibiotic susceptibility testing in positive patients or avoid unnecessary biopsies in negative patients.
