Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy.
Division of Gastroenterology and Digestive Endoscopy, Humanitas Research Hospital - IRCCS, Via Manzoni 56, 20089, Rozzano, Milano, Italy.
Hepatobiliary Pancreat Dis Int. 2024 Feb;23(1):71-76. doi: 10.1016/j.hbpd.2023.04.002. Epub 2023 Apr 11.
Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy.
This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate.
A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding.
Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.
与十二指肠镜相关的多药耐药菌（MDRO）感染引起了人们的关注。 最近市场上推出了一次性使用的十二指肠镜，并已获得监管机构的批准，旨在降低内镜逆行胰胆管造影术（ERCP）相关感染的风险。 本研究的目的是评估在具有单操作员胆管胰腺镜检查临床适应证的患者中使用一次性使用十二指肠镜进行操作的结果。
这是一项多中心国际回顾性研究，结合了所有接受过复杂的胰胆管介入治疗的患者，这些患者使用一次性使用的十二指肠镜和一次性使用的胆道镜联合治疗。 主要结果是技术成功，定义为符合预期临床适应证的 ERCP 完成。 次要结果是操作持续时间，改用可重复使用的十二指肠镜的比例，操作员报告的对一次性使用十二指肠镜性能评分的满意度（1 到 10 分）以及不良事件（AE）发生率。
共有 66 名患者（26 名，39.4％为女性）纳入本研究。 根据 ASGE ERCP 分级系统，ERCP 分为 47 例（71.2％）3 级和 19 例（28.8％）4 级。 技术成功率为 98.5％（65/66）。 操作持续时间为 64 分钟（四分位间距 15-189 分钟），改用可重复使用的十二指肠镜的比例为 1/66（1.5％）。 操作人员对一次性使用十二指肠镜的满意度评分分类为 8.6 ± 1.3 分。 有 4 名患者（6.1％）发生了与一次性使用十二指肠镜无关的 AE，分别为 2 例 ERCP 后胰腺炎（PEP），1 例胆管炎和 1 例出血。
即使在技术上具有挑战性的操作中，一次性使用的十二指肠镜也是有效，可靠且安全的，与可重复使用的十二指肠镜相比无劣势，因此这些设备是标准可重复使用设备的可行替代方案。
