Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography
Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography
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DOI：
10.1016/j.cgh.2019.10.052
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发表时间：
2020-08-01
影响因子：
12.6
通讯作者：
Ross, Andrew S.
中科院分区：
文献类型：
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作者：
Muthusamy, V. Raman;Bruno, Marco J.;Ross, Andrew S.
背景与目的：一次性使用内窥镜可能会减少与内窥镜重复使用相关的感染爆发。我们测试了一种新型一次性十二指肠镜在接受内镜逆行胰胆管造影术（ERCP）的患者中的可行性、初步安全性和性能。方法：我们对2019年4月至5月在6个学术医疗中心使用一次性十二指肠镜进行的ERCP结局进行了病例系列研究。我们筛选了连续的患者（18岁及以上），胰胆解剖结构没有改变，并招募了73例患者进入研究。7名内窥镜专家对13名患者进行了滚入操作（仅十二指肠镜导航和十二指肠乳头可视化），然后对其他60名患者进行了ERCP。分析的结果包括完成ERCP的预期临床适应症，交叉从一次性使用的十二指肠镜到可重复使用的十二指肠镜，内窥镜的性能评级的设备，和严重不良事件（在72小时和7天评估）。ERCP为美国胃肠内镜学会手术复杂性1级（最不复杂; 7例患者[11.7%]）、2级（26例患者[43.3%]）、3级（26例患者[43.3%]）和4级（最复杂; 1例患者[1.7%]）。仅使用一次性十二指肠镜完成了58例ERCP（96.7%），使用一次性十二指肠镜完成了2例ERCP（3.3%），然后交叉使用可重复使用的十二指肠镜。总体满意度中位数为9/10。3例患者ERCP后胰腺炎，1例括约肌切开术后出血，1例患者恶化的既存感染，并需要rehospitalis.CONCLUSIONS：在一项病例系列研究中，我们发现，专家内镜可以完成ERCP的复杂性范围广泛，使用一次性使用的十二指肠镜几乎所有的情况下。这种替代方案可能会降低ERCP相关的感染风险。Clinicaltrials.gov编号：NCT 03701958。
BACKGROUND & AIMS: Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).METHODS: We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events (assessed at 72 hours and 7 days).RESULTS: Thirteen (100%) roll-in maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization.CONCLUSIONS: In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958.