The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.

Difficult biliary stones Endoscopic retrograde cholangiopancreatography Indeterminate biliary stricture Single-operator cholangioscopy Single-use duodenoscope

Journal

Hepatobiliary & pancreatic diseases international : HBPD INT
ISSN: 1499-3872
Titre abrégé: Hepatobiliary Pancreat Dis Int
Pays: Singapore
ID NLM: 101151457

Informations de publication

Date de publication:
11 Apr 2023
Historique:
received: 04 08 2022
accepted: 06 04 2023
medline: 27 4 2023
pubmed: 27 4 2023
entrez: 26 4 2023
Statut: aheadofprint

Résumé

Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy. This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate. A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding. Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

Sections du résumé

BACKGROUND BACKGROUND
Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy.
METHODS METHODS
This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate.
RESULTS RESULTS
A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding.
CONCLUSIONS CONCLUSIONS
Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

Identifiants

DOI: 10.1016/j.hbpd.2023.04.002 PMID: 37100688
pubmed: 37100688
pii: S1499-3872(23)00047-4
doi: 10.1016/j.hbpd.2023.04.002
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023 First Affiliated Hospital, Zhejiang University School of Medicine in China. Published by Elsevier B.V. All rights reserved.

Auteurs

Alessandro Fugazza (A)

Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy. Electronic address: alessandro.fugazza@humanitas.it.

Matteo Colombo (M)

Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy.

Michel Kahaleh (M)

Gastroenterology, Rutgers Robert Wood Johnson; New Brunswick, New Jersey, USA.

V Raman Muthusamy (VR)

Vatche and Tamar Manoukian Division of Digestive Diseases, University of California, Los Angeles School of Medicine at UCLA, Los Angeles, California, USA.

Bick Benjamin (B)

Division of Digestive and Liver Disorders; Indiana University School of Medicine, Indianapolis, IN, USA.

Wim Laleman (W)

Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, 3000 Leuven, Belgium.

Carmelo Barbera (C)

U.O.C. di Gastroenterologia ed Endoscopia Digestiva, Ospedale Giuseppe Mazzini, ASL Teramo, Italy.

Carlo Fabbri (C)

Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals, AUSL Romagna, Forlì-Cesena, Italy.

Jose Nieto (J)

Borland Groover Clinic, Jacksonville, Florida, USA.

Abed Al-Lehibi (A)

Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia.

Mohan Ramchandani (M)

Asian Institute of Gastroenterology, Hyderabad, India.

Amy Tyberg (A)

Gastroenterology, Rutgers Robert Wood Johnson; New Brunswick, New Jersey, USA.

Haroon Shahid (H)

Gastroenterology, Rutgers Robert Wood Johnson; New Brunswick, New Jersey, USA.

Avik Sarkar (A)

Gastroenterology, Rutgers Robert Wood Johnson; New Brunswick, New Jersey, USA.

Dean Ehrlich (D)

Vatche and Tamar Manoukian Division of Digestive Diseases, University of California, Los Angeles School of Medicine at UCLA, Los Angeles, California, USA.

Stuart Sherman (S)

Division of Digestive and Liver Disorders; Indiana University School of Medicine, Indianapolis, IN, USA.

Cecilia Binda (C)

Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals, AUSL Romagna, Forlì-Cesena, Italy.

Marco Spadaccini (M)

Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy.

Andrea Iannone (A)

Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy.

Kareem Khalaf (K)

Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy.

Nageshwar Reddy (N)

Asian Institute of Gastroenterology, Hyderabad, India.

Andrea Anderloni (A)

Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy.

Alessandro Repici (A)

Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy.

Classifications MeSH