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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

摘要Background:Duodenoscope-related multidrug-resistant organism(MDRO)infections raise concerns.Dis-posable 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 in-fections.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 in-tended 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 duo-denoscope,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 pro-cedures with a non-inferiority to reusable duodenoscope,making these devices a viable alternative to standard reusable equipment.

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作者 Alessandro Fugazza [1] Matteo Colombo [1] Michel Kahaleh [2] V.Raman Muthusamy [3] Bick Benjamin [4] Wim Laleman [5] Carmelo Barbera [6] Carlo Fabbri [7] Jose Nieto [8] Abed Al-Lehibi [9] Mohan Ramchandani [10] Amy Tyberg [2] Haroon Shahid [2] Avik Sarkar [2] Dean Ehrlich [3] Stuart Sherman [4] Cecilia Binda [7] Marco Spadaccini [1] Andrea Iannone [11] Kareem Khalaf [12] Nageshwar Reddy [10] Andrea Anderloni [1] Alessandro Repici [13] 学术成果认领
作者单位 Division of Gastroenterology and Digestive Endoscopy,Humanitas Research Hospital-IRCCS,Via Manzoni 56,20089,Rozzano,Milano,Italy [1] Gastroenterology,Rutgers Robert Wood Johnson;New Brunswick,New Jersey,USA [2] Vatche and Tamar Manoukian Division of Digestive Diseases,University of California,Los Angeles School of Medicine at UCLA,Los Angeles,California,USA [3] Division of Digestive and Liver Disorders;Indiana University School of Medicine,Indianapolis,IN,USA [4] Department of Gastroenterology and Hepatology,University Hospitals Leuven,KU Leuven,3000 Leuven,Belgium [5] U.O.C.di Gastroenterologia ed Endoscopia Digestiva,Ospedale Giuseppe Mazzini,ASL Teramo,Italy [6] Gastroenterology and Digestive Endoscopy Unit,Forlì-Cesena Hospitals,AUSL Romagna,Forlì-Cesena,Italy [7] Borland Groover Clinic,Jacksonville,Florida,USA [8] Department of Gastroenterology and Hepatology,King Fahad Medical City,Riyadh,Saudi Arabia [9] Asian Institute of Gastroenterology,Hyderabad,India [10] Section of Gastroenterology,Department of Emergency and Organ Transplantation,University of Bari,Bari 70124,Italy [11] Department of Biomedical Sciences,Humanitas University,Via Rita Levi Montalcini 4,20090,Pieve Emanuele,Milan,Italy [12] 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 [13]
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DOI 10.1016/j.hbpd.2023.04.002
发布时间 2024-03-01
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