Department of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Department of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington, USA.
Gastrointest Endosc. 2021 Dec;94(6):1046-1055. doi: 10.1016/j.gie.2021.06.017. Epub 2021 Jun 26.
Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience.
Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events.
Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%).
In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).
专家内镜医师此前曾报道过首款商业化一次性使用十二指肠镜的 ERCP 结果。我们旨在记录不同 ERCP 经验水平的内镜医师对该设备的可用性。
14 名“专家”（>2000 例终生 ERCP）和 5 名“非专家”内镜医师对无胰腺胆道解剖结构改变的患者连续进行 ERCP。结果包括根据预期适应证完成 ERCP、改用另一台内镜的比例、设备性能评分和严重不良事件。
共进行了 200 例 ERCP，其中 81 例（40.5%）为高复杂性（美国胃肠内镜学会分级 3-4 级）。改用另一台内镜的比例（11.3%比 2.5%，P=0.131）、无论是否改用另一台内镜，完成 ERCP 的比例（96.3%比 97.5%，P=0.999）、中位 ERCP 完成时间（25.0 比 28.5 分钟，P=0.130）、平均插管尝试次数（2.8 比 2.8，P=0.954）和对一次性使用十二指肠镜的总体满意度（8.0 比 8.0[范围，1.0-10.0]，P=0.840）在专家和非专家内镜医师之间相似。除了 1 级至 2 级与 3 级至 4 级相比，中位完成时间更短（P<0.001）外，这些指标在手术复杂性方面也相似。13 例患者（6.5%）报告了严重不良事件。
在连续的 ERCP 中，包括高复杂性手术，具有不同 ERCP 经验的内镜医师具有良好的手术成功率，并报告了较高的设备性能评分。（临床试验注册号：NCT04223830）。
