Systematic Reviews
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Methodol. May 20, 2022; 12(3): 122-131
Published online May 20, 2022. doi: 10.5662/wjm.v12.i3.122
Single-use duodenoscopes for the prevention of endoscopic retrograde cholangiopancreatography -related cross-infection – from bench studies to clinical evidence
Andrea Lisotti, Pietro Fusaroli, Bertrand Napoleon, Anna Cominardi, Rocco Maurizio Zagari
Andrea Lisotti, Pietro Fusaroli, Anna Cominardi, Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola 40026, BO, Italy
Bertrand Napoleon, Gastroenterology Unit, Hôpital privé Jean Mermoz - Ramsay Générale de Santé, Lyon 69008, FR, France
Rocco Maurizio Zagari, Dipertimento Di Scienze Mediche e Chirurgiche, Università di Bologna, Policlinico San Orsola Malpighi, Bologna 40138, Italy
Author contributions: Lisotti A and Fusaroli P wrote the paper; Napoléon B, Cominardi A and Zagari RM performed data collection for systematic review; all authors reviewed manuscript for pivotal intellectual content.
Conflict-of-interest statement: Authors declare no conflicts of interest for this article.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
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: Andrea Lisotti, MD, MSc, Adjunct Professor, Gastroenterology Unit, Hospital of Imola, University of Bologna, via Montericco 4, Imola 40026, BO, Italy. lisotti.andrea@gmail.com
Received: November 28, 2021
Peer-review started: November 28, 2021
First decision: January 12, 2022
Revised: January 16, 2022
Accepted: March 16, 2022
Article in press: March 16, 2022
Published online: May 20, 2022
ARTICLE HIGHLIGHTS
Research background

Single-use duodenoscope use has been proposed as an effective strategy to avoid the risk of duodenoscope-related cross-infections in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).

Research motivation

Recentaly, several manuscript have been published reporting the ouctomes of clinical studies on single-use duodenoscope use for ERCP.

Research objectives

To perform a systematic review of the literature and report qualitative and quantitative results in terms of technical success rate, clinical success, and safety.

Research methods

Systematic review and quantitative analysis.

Research results

Five original articles have been identified. One bench comparative study and four clinical trials performed with EXALT model-D (Boston Scientific Corp., United States) have been identified. Of them, one is a randomized controlled trial, while the other three studies are prospective single-arm, cross-over studies. Pooled technical success rate (4 studies, 368 patients) was 92.9% [95% confidence interval (CI): 89.9-95.5; I2: 11.8%]. Pooled serious adverse event (4 studies, 381 patients) rate was 5.9% [3.7%-8.5%; I2: 0.0%].

Research conclusions

Although few clinical trials are available, evidence is concordant in identifying an absolute feasibility and safety and feasibility for single-use duodenoscopes (SUD) use for ERCP. Data on cost-effectiveness and environmental impact will be needed for a worldwide spread of SUD use for ERCP.

Research perspectives

Future perspective and study pipelines should assess the use of other models of single-use duodenoscope, cost-effectiveness of single-use duodenoscope use for ERCP and environmental sustainability.