Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
JAMA Intern Med. 2023 Mar 1;183(3):191-200. doi: 10.1001/jamainternmed.2022.6394.
Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument.
To determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs.
DESIGN, SETTING, AND PARTICIPANTS: In this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible.
The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design.
Coprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers.
From December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes.
In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP.
ClinicalTrials.gov Identifier: NCT04040504.
尽管高水平消毒可以彻底消除器械上的微生物，但由于十二指肠镜持续污染，内镜逆行胰胆管造影（ERCP）后仍可能发生感染传播。
确定（1）高水平消毒后污染率，（2）一次性提升帽十二指肠镜与标准设计十二指肠镜的技术性能。
设计、地点和参与者：这是在加拿大 2 个三级 ERCP 中心进行的平行臂多中心随机临床试验，所有年龄在 18 岁及以上且因任何适应症接受 ERCP 的患者均符合条件。
干预措施为使用一次性提升帽十二指肠镜与标准设计十二指肠镜进行比较。
主要结局为十二指肠镜提升器或通道持续存在微生物污染，定义为高水平消毒后生长至少 10 个菌落形成单位的任何生物体或任何革兰氏阴性菌生长（优势结果），以及根据预先设定的标准（非劣效性界值为 7%）评估的 ERCP 技术成功（具有预先设定的非劣效性边界值的非劣效性结果），由盲法评审员评估。
2019 年 12 月至 2022 年 2 月，共纳入 518 例患者（259 例一次性提升帽十二指肠镜，259 例标准十二指肠镜）。患者平均（SD）年龄为 60.7（17.0）岁，258 例（49.8%）为女性。两组间无显著差异，包括 ERCP 难度。标准十二指肠镜中持续微生物污染发生率为 11.2%（24/214），一次性提升帽十二指肠镜为 3.8%（8/208）（P = .004），相应的相对风险为 0.34（95%CI，0.16-0.75），需要治疗的病例数为 13.6（95%CI，8.1-42.7），以避免持续污染。使用一次性帽镜的技术成功率不劣于标准镜（94.6%比 90.7%，P = .13）。两组间不良事件和其他次要结局无差异。
在这项随机临床试验中，与标准镜设计相比，一次性提升帽十二指肠镜在高水平消毒后显示出减少的污染，而不影响 ERCP 的技术性能和安全性。
ClinicalTrials.gov 标识符：NCT04040504。
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