Comparison of procedure-related complications and success rates between duodenoscopes with disposable end caps and...

Duodenoscopes with disposable distal end caps (DDEC) have been introduced to reduce the risk of transmitting multi-drug-resistant organisms compared to conventional reusable duodenoscopes (CRD). However, there have been reports of increased procedure-related complications with DDEC. This study aims to compare the complication rate and procedure success rate between DDEC and CRD.

Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) were randomized to either the DDEC or CRD group. The primary outcomes were procedure-related complications, while secondary outcomes included procedure success rates and technical performance characteristics.

A total of 319 patients were randomized, with 159 assigned to the DDEC group and 160 to the CRD group. The mean age of the patients was 65 years (range 50-72.5), and 40.8% were women. The study was terminated prematurely following interim analysis due to futility. There was no significant difference in procedure-related complications between the two groups (9 vs. 9; p > 0.05). Cap detachment did not occur in any of the patients in the DDEC group, and no patients in either group developed bacteremia within 3 months post-procedure. Additionally, there was no significant difference in procedure success rates between the two groups (154 vs. 155; p = 0.9).

Duodenoscopes with disposable end caps are safe and demonstrate comparable procedural characteristics to conventional reusable duodenoscopes.