Study: Single-Use Duodenoscopes Effective Across Endoscopist Experience Levels

Preventing Infection

Study: Single-Use Duodenoscopes Effective Across Endoscopist Experience Levels

Single-use duodenoscopes “can reduce the risk of exogenous contamination associated with” ERCP and help facilitate endoscopy in departments without reprocessing capability.

Endoscopists with varying experience levels across a wide geographic area had high procedural success using single-use duodenoscopes for endoscopic retrograde cholangiopancreatography (ERCP) procedures.

That’s according to a poster describing a large observational study of single-use duodenoscopes on a broad range of cases. It was presented last month at DDW 2023 in Chicago and the research found success in one-third of high-complexity cases and reported high performance ratings for this device.

The study included 551 ERCP procedures done by 61 endoscopists at 22 academic centers across 11 countries. It analyzed completion rates, mean cannulation attempts, rate of crossover to a reusable duodenoscope, device performance ratings, median completion time and serious adverse events.

Here’s what the data revealed:

  • 529 (96%) ERCP procedures were completed
  • 503 (91.3%) were completed using only the single-use duodenoscope and 26 (4.7%) with crossover to a reusable endoscope
  • 22 (4%) ERCP procedures were not completed — 11 of which included a crossover and 11 that were aborted cases
  • Median satisfaction with the single-use duodenoscope was 8 overall on a scale of 1-10
  • ERCP completion rate did not differ significantly between expert (greater than 2,000 lifetime ERCPs) and non-experts or by ASGE complexity grade
  • Median ERCP completion time was 24 minutes with significantly longer time for higher ASGE grade (35.5 minutes for grades 3-4 versus 20 minutes for grades 1-2)
  • 43 (7.8%) patients reported one or more serious adverse events related to the ERCP and/or duodenoscopes, with pancreatitis being the most common

Single-use duodenoscopes “can reduce the risk of exogenous contamination associated with” ERCP and help facilitate endoscopy in departments without reprocessing capability, the researchers write in the poster’s introduction.

Recently, the U.S. Food and Drug Administration recommended that hospitals and endoscopy facilities transition to duodenoscopes with innovative designs that “make reprocessing easier, more effective, or unnecessary.”

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