Department of Gastroenterology and Hepatology, Erasmus Medical Center, University Medical Center, Rotterdam, The Netherlands.
Department of Internal Medicine, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.
Endoscopy. 2023 Dec;55(12):1103-1114. doi: 10.1055/a-2131-7180. Epub 2023 Jul 18.
The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas.
61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs).
Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis.
In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.
美国食品和药物管理局于 2019 年 12 月批准了首款商业化的一次性使用十二指肠镜。需要在更广泛的病例范围内，由不同经验水平的内镜医生在广泛的地理区域内使用一次性使用十二指肠镜进行内镜逆行胰胆管造影术（ERCP）的数据。
来自 11 个国家 22 个学术中心的 61 名内镜医生对年龄≥18 岁的成年患者进行了 ERCP 操作。结果包括针对预期适应证完成 ERCP、改用可重复使用的内窥镜的比例、设备性能评分和严重不良事件（SAE）。
在 551 名患者中，236 名（42.8%）年龄>65 岁，281 名（51.0%）为男性，256 名（46.5%）为住院患者。ERCP 包括 196 例（35.6%）美国胃肠内镜学会（ASGE）分级 3-4 级。共完成 529 例 ERCP（96.0%）：仅使用一次性十二指肠镜完成 503 例（91.3%），改用可重复使用的内窥镜完成 26 例（4.7%）。有 22 例 ERCP（4.0%）未完成，其中 11 例（2.0%）改行可重复使用的内窥镜，11 例（2.0%）为中止病例（无改行）。ERCP 完成时间中位数为 24.0 分钟。对一次性十二指肠镜的总体满意度中位数为 8.0（1-10 分，满分）。43 例（7.8%）患者报告出现严重不良事件，包括 17 例（3.1%）发生 ERCP 后胰腺炎。
在广泛地理分布的学术医疗中心中，具有不同经验水平的内镜医生使用首款市售一次性使用十二指肠镜进行 ERCP 取得了良好的手术成功率，并对该设备的性能评价较高。
