Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography
Authors: Forbes Nauzer , Elmunzer B. Joseph , Allain Thibault , Parkins Michael D. , Sheth Prameet M. , Waddell Barbara J. , Du Kristine , Douchant Katya , Oladipo Olajumoke , Saleem April , Cartwright Shane , Chau Millie , Howarth Megan , McKay Jackie , Nashad Tamim , Ruan Yibing , Bishay Kirles , Gonzalez-Moreno Emmanuel , Meng Zhao Wu , Bass Sydney , Bechara Robert , Cole Martin J. , Jalink Diederick W. , Mohamed Rachid , Turbide Christian , Belletrutti Paul J. , Kayal Ahmed , Kumar Puja R. , Hilsden Robert J. , Buret André G. , Hookey Lawrence , Heitman Steven J. 
Published: January 2023

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