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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