Large Single-Use Duodenoscope Experience Shows High Success and Low Crossover Rates

Single-use duodenoscopes were developed to eliminate the risk of duodenoscope-associated transmission of infections. However, there are concerns that the performance of single-use duodenoscopes may not be optimal in practice. Limited data exist on the outcomes of ERCP using these endoscopes. 

In this industry-sponsored study, 61 endoscopists (22 centers) performed ERCP in 551 patients using a commercially available single-use duodenoscope (Exalt, Boston Scientific Corporation, Marlborough, Mass). Endoscopists were stratified by volume as expert (>2000 lifetime ERCPs; 46 endoscopists) or less-expert (≤2000 lifetime ERCPs; 15 endoscopists). ERCPs were categorized as difficult using previously described criteria such as more than 5 contacts with the papilla while attempting to cannulate, more than 5 minutes spent attempting to cannulate following visualization of the papilla, and unintended pancreatic duct cannulation or opacification. 

In total, 55.9% of patients had native papillae (no prior sphincterotomy), and 37 (6.7%) underwent an ERCP procedure with crossover from a single-use to a reusable duodenoscope. Overall, difficult cannulation was seen in 29.2% of all ERCPs; among these cases, 2.9% underwent crossover to a reusable duodenoscope. The overall success rate for ERCP with single-use duodenoscopes was 91.3%; an additional 4.7% of patients had a successful ERCP after crossover to a reusable duodenoscope. ERCP performance, including ERCP success and crossover rates, was similar between experts and less-experts, but experts rated single-use duodenoscopes higher than less-experts. The overall pancreatitis rate was 3.3%, and the overall adverse event rate was 7.8%.