Global prospective case series of ERCPs using a single-use duodenoscope

Area of Science:

• Gastroenterology
• Medical Devices
• Endoscopy

Background:

• The first single-use duodenoscope was FDA-cleared in December 2019.
• Data on single-use duodenoscope use in endoscopic retrograde cholangiopancreatography (ERCP) are needed across varied cases and experience levels.

Purpose of the Study:

• To evaluate the performance and safety of the first commercialized single-use duodenoscope in ERCP procedures.
• To assess ERCP completion rates, device performance, and adverse events across multiple international academic centers.

Main Methods:

• 61 endoscopists at 22 academic centers in 11 countries performed ERCP on 551 adult patients.
• Outcomes included ERCP completion, crossover to reusable devices, device performance ratings, and serious adverse events (SAEs).

Main Results:

• ERCP was completed in 96.0% of cases using the single-use duodenoscope, with 91.3% completed without crossover.
• Median completion time was 24.0 minutes, and median satisfaction was 8.0/10.
• Serious adverse events (SAEs) occurred in 7.8% of patients, including post-ERCP pancreatitis in 3.1%.

Conclusions:

• The first marketed single-use duodenoscope demonstrated good ERCP procedural success in academic centers.
• Endoscopists with varying experience levels reported high performance ratings for the device.
• The study supports the utility of single-use duodenoscopes in diverse ERCP settings.