Single-use duodenoscopes safe and effective for use in ERCPs

Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure that combines upper gastrointestinal (GI) endoscopy and x-rays to treat problems of the bile and pancreatic ducts. Doctors state they prefer ERCP to diagnose problems of the bile and pancreatic ducts if they expect to treat problems during the procedure. However its safety is a question as it’s a invasive procedure.

A new study in the journal Endoscopy reveals that endoscopists in several academic medical centers over the globe with varying levels of experience who used the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

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.