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
Alessandro Fugazza a , ∗, Matteo Colombo a , Michel Kahaleh b , V. Raman Muthusamy c , Bick Benjamin d , Wim Laleman e , Carmelo Barbera f , Carlo Fabbri g , Jose Nieto h , Abed Al-Lehibi i , Mohan Ramchandani j , Amy Tyberg b , Haroon Shahid b , Avik Sarkar b , Dean Ehrlich c , Stuart Sherman d , Cecilia Binda g , Marco Spadaccini a , Andrea Iannone k , Kareem Khalaf l , Nageshwar Reddy j , Andrea Anderloni a , Alessandro Repici a , l
a Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy
b Gastroenterology, Rutgers Robert Wood Johnson; New Brunswick, New Jersey, USA
c Vatche and Tamar Manoukian Division of Digestive Diseases, University of California, Los Angeles School of Medicine at UCLA, Los Angeles, California, USA
d Division of Digestive and Liver Disorders; Indiana University School of Medicine, Indianapolis, IN, USA
e Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, 3000 Leuven, Belgium
f U.O.C. di Gastroenterologia ed Endoscopia Digestiva, Ospedale Giuseppe Mazzini, ASL Teramo, Italy
g Gastroenterology and Digestive Endoscopy Unit, Forlì-Cesena Hospitals, AUSL Romagna, Forlì-Cesena, Italy
h Borland Groover Clinic, Jacksonville, Florida, USA i Department of Gastroenterology and Hepatology, King Fahad Medical City, Riyadh, Saudi Arabia
j Asian Institute of Gastroenterology, Hyderabad, India
k Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari 70124, Italy
l Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy
Abstract：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: 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: 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 points. 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: 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.
. [J]. Hepatobiliary Pancreat Dis Int, 2024, 23(1): 71-76.
Fugazza A, Colombo M, Kahaleh M, Muthusamy VR, Benjamin B, Laleman W, Barbera C, Fabbri C, Nieto J, Al-Lehibi A,. 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. Hepatobiliary Pancreat Dis Int, 2024, 23(1): 71-76.
2024, Vol. 23 
