Abstract

Background and Aims

In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope.

Methods

We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures.

Results

Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation.

Conclusion

Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice.

中文翻译：

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一次性十二指肠镜的学习曲线评估

摘要

背景和目标

为了应对已记录的与十二指肠镜相关的多重耐药微生物感染暴发，美国食品和药物管理局建议过渡到采用创新设计的十二指肠镜，包括带有一次性组件的十二指肠镜或完全一次性十二指肠镜。我们的目标是描述一次性十二指肠镜的学习曲线 (LC)。

方法

我们对前瞻性收集的 31 名患者的数据库进行了回顾性分析，这些患者由一位经验丰富的操作员在一家三级转诊中心使用 EXALT Model D®（波士顿科学公司，马尔堡）一次性十二指肠镜接受了 ERCP。该设备的 LC 通过使用累积和 (CUSUM) 分析达到熟练程度所需的案例数量来描述。尝试对所需导管进行插管的次数和对所需导管进行插管的时间作为单独的终点进行评估。总平均尝试次数和总平均插管时间被用作各自 CUSUM 分析中的目标值。熟练程度定义为累积和图中达到拐点的程序数量。这一观察结果表明操作员的表现得到了改善，如在规定次数的手术后尝试次数的减少和插管时间的缩短所表明的。

结果

总体而言，由一位经验丰富的内窥镜医师使用 EXALT D 型一次性十二指肠镜对 31 名患者进行了 ERCP。6 名 (19%) 患者具有天然乳头，其中大多数手术被归类为 ASGE 复杂性 2 级或以上。27 名患者（87%）仅使用一次性十二指肠镜完成了手术，而 4 名患者（13%）则需要使用可重复使用的十二指肠镜来完成手术。交叉在整个表演期间均匀分布。手术相关不良事件包括：ERCP 术后胰腺炎（3%）、出血（3%）和无穿孔。在对两个终点的分析中，有 10 个病例出现了 CUSUM 曲线的拐点，表明插管尝试和插管时间持续减少。

结论

在经验丰富的胰胆内窥镜医师中，大约 10 次 ERCP 是改善手术相关因素（包括插管成功和手术时间）的阈值。与手术相关的不良事件与可重复使用十二指肠镜预期的不良事件一致。从一次性十二指肠镜交叉到可重复使用十二指肠镜的需求似乎与学习曲线无关，因为它们在整个研究期间均匀分布。这些结果可用于指导一次性十二指肠镜在临床实践中的采用。