Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized endoscopes used to perform ERCP, and inherent to their design, a high rate of persistent bacterial contamination exists even after automated reprocessing and disinfection. Consequently, in recent years, ERCP has been associated with infection transmission, leading to several fatal patient outbreaks. Due to increasing fears over widespread future duodenoscope-related outbreaks, regulatory bodies have called for alterations in the design of duodenoscopes. A duodenoscope has recently been developed that employs a disposable cap. This novel design theoretically eliminates the mechanism behind persistent bacterial contamination and infection transmission. However, there are no data demonstrating persistent bacterial contamination rates, technical success rates, or clinical outcomes associated with these duodenoscopes. A parallel arm randomized controlled trial will be performed for which 520 patients will be recruited. The study population will consist of consecutive patients undergoing ERCP procedures for any indication at a high-volume tertiary care centre in Calgary, Alberta, Canada. Patients will be randomized to an intervention group, that will undergo ERCP with a novel duodenoscope with disposable cap, or to a control group who will undergo ERCP with a traditional duodenoscope. Co-primary outcomes will include persistent bacterial contamination rates (post automated reprocessing) and ERCP technical success rates. Secondary outcomes include clinical success rates, overall and specific early and late adverse event rates, 30-day mortality and healthcare utilization rates, procedure and reprocessing times, and ease of device use. The ICECAP trial will answer important questions regarding the use of a novel duodenoscope with disposable cap. Specifically, persistent bacterial contamination, technical performance, and relevant clinical outcomes will be assessed. Given the mortality and morbidity burden associated with ERCP-related infectious outbreaks, the results of this study have the capacity to be impactful at an international level. This trial was registered on clinicaltrials.gov (NCT04040504) on July 31, 2019.

中文翻译：

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使用带一次性帽的十二指肠镜 (ICECAP) 进行 ERCP 感染控制：随机对照试验的基本原理和设计


内窥镜逆行胰胆管造影（ERCP）通常用于治疗胰腺和胆道疾病。十二指肠镜是用于执行 ERCP 的专用内窥镜，由于其设计固有的特点，即使在自动再处理和消毒后，仍然存在高比例的持续细菌污染。因此，近年来，ERCP 与感染传播相关，导致多起患者死亡事件。由于人们越来越担心未来与十二指肠镜相关的广泛爆发，监管机构呼吁改变十二指肠镜的设计。最近开发了一种采用一次性帽的十二指肠镜。这种新颖的设计从理论上消除了持续细菌污染和感染传播背后的机制。然而，没有数据证明与这些十二指肠镜相关的持续细菌污染率、技术成功率或临床结果。将进行一项平行组随机对照试验，招募 520 名患者。研究人群将包括在加拿大艾伯塔省卡尔加里的一个大容量三级护理中心接受任何适应症的 ERCP 手术的连续患者。患者将被随机分配到干预组，使用带一次性帽的新型十二指肠镜进行 ERCP，或对照组，使用传统十二指肠镜进行 ERCP。共同主要结果将包括持续细菌污染率（自动再处理后）和 ERCP 技术成功率。 次要结果包括临床成功率、总体和特定的早期和晚期不良事件发生率、30 天死亡率和医疗保健利用率、手术和再处理时间以及设备使用的便利性。 ICECAP 试验将回答有关使用带有一次性帽的新型十二指肠镜的重要问题。具体来说，将评估持续的细菌污染、技术性能和相关的临床结果。考虑到与 ERCP 相关的传染病爆发相关的死亡率和发病率负担，这项研究的结果有能力在国际层面产生影响。该试验于 2019 年 7 月 31 日在 ClinicalTrials.gov (NCT04040504) 上注册。