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. 2023 Mar 1;183(3):191-200.
doi: 10.1001/jamainternmed.2022.6394.

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial

Nauzer Forbes  1   2 , B Joseph Elmunzer  3 , Thibault Allain  4 , Michael D Parkins  5   6 , Prameet M Sheth  7   8 , Barbara J Waddell  5 , Kristine Du  5 , Katya Douchant  7 , Olajumoke Oladipo  9 , April Saleem  8 , Shane Cartwright  1 , Millie Chau  1 , Megan Howarth  1 , Jackie McKay  10 , Tamim Nashad  1 , Yibing Ruan  11   10 , Kirles Bishay  1 , Emmanuel Gonzalez-Moreno  1 , Zhao Wu Meng  1 , Sydney Bass  1 , Robert Bechara  12 , Martin J Cole  1 , Diederick W Jalink  13 , Rachid Mohamed  1 , Christian Turbide  1 , Paul J Belletrutti  1 , Ahmed Kayal  1 , Puja R Kumar  1 , Robert J Hilsden  1   2 , André G Buret  4 , Lawrence Hookey  12 , Steven J Heitman  1   2
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Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial

Nauzer Forbes et al. JAMA Intern Med. .

Abstract

Importance: 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.

Objective: 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.

Intervention: The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design.

Main outcomes and measures: 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.

Results: 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.

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT04040504.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Forbes reported nonfinancial support from Pentax Medical (temporary use of study devices) during the conduct of the study and personal fees from Boston Scientific (speaking fees, consulting fees, post-marketing surveillance), Pentax Medical (speaking fees, consulting fees, grants), and AstraZeneca (consulting fees) outside the submitted work. Dr Bechara is a consultant for and has received speaker’s fees from Olympus and Pentax Medical and has received speaker’s fees from Pendopharm Inc. Dr Belletrutti is a consultant for Pentax Medical and is on the speaker’s bureau for Pentax Medical and Pendopharm Inc. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagram of Screening, Randomization, Analyses of Coprimary Outcomes, and Follow-up
DEC indicates disposable elevator cap; SD, standard duodenoscope.
Figure 2.
Figure 2.. Subgroup Analyses for Coprimary Outcomes
Relative risks are presented with standard duodenoscopes as the reference comparator. ASGE indicates American Society for Gastrointestinal Endoscopy; ERCP, endoscopic retrograde cholangiopancreatography; RR, relative risk. Note: among the ERCPs with biliary stent placement, technical success was 100% in both arms, and there were 0 cases of persistent contamination in the disposable elevator cap arm—therefore, no point estimates are provided for this subgroup given that RRs and/or CIs are inestimable.
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