Surgical endoscopy · 2026
Comparison of procedure-related complications and success rates between duodenoscopes with disposable end caps and conventional reusable duodenoscopes: a randomized trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Siddappa Pradeep K, Barakat Monique T, Zhou Margaret J, Li Andrew A, Eldika Samer, Banerjee Subhas
Аннотация
BACKGROUND AND AIMS: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSION: Duodenoscopes with disposable end caps are safe and demonstrate comparable procedural characteristics to conventional reusable duodenoscopes.
METHODS: 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.
RESULTS: 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).
CONCLUSION: Duodenoscopes with disposable end caps are safe and demonstrate comparable procedural characteristics to conventional reusable duodenoscopes.