Single-use duodenoscopes safe and effective for use in ERCPs

Study included 61 endoscopists at 22 academic centers in 11 countries who performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs).

The key findings of the study are

• A total of 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient.

• ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3–4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope.

• There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover).

• Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]).

• SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis.

Researchers concluded that “In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.”

Reference: Marco J. Bruno, Torsten Beyna, David Carr-Locke et al; Global prospective case series of ERCPs using a single-use duodenoscope; Endoscopy, DOI: 10.1055/a-2131-7180.