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Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of
Nauzer Forbes1,2, B Joseph Elmunzer3, Thibault Allain4
1Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
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.
Insights
Disposable elevator cap duodenoscopes significantly reduced contamination after high-level disinfection compared to standard designs. This innovation enhances patient safety in endoscopic retrograde cholangiopancreatography (ERCP) procedures without compromising technical success.
Area of Science:
- Gastroenterology
- Infectious Disease Control
- Medical Device Innovation
Background:
- Persistent contamination of duodenoscopes after high-level disinfection poses an infection risk during endoscopic retrograde cholangiopancreatography (ERCP).
- Standard duodenoscope designs present challenges in achieving complete microbial elimination, necessitating improved disinfection protocols or device modifications.
Purpose of the Study:
- To evaluate the contamination rates of duodenoscopes with disposable elevator caps versus standard designs after high-level disinfection.
- To assess the technical performance and safety of duodenoscopes with disposable elevator caps in ERCP procedures.
Main Methods:
- A parallel-arm, multicenter randomized clinical trial involving 518 patients undergoing ERCP.
- Comparison of duodenoscopes featuring disposable elevator caps against those with standard designs.
- Coprimary outcomes included microbial contamination rates and technical success of ERCP, assessed by blinded reviewers.
Main Results:
- Disposable elevator cap duodenoscopes showed significantly lower persistent microbial contamination rates (3.8%) compared to standard duodenoscopes (11.2%) (P=.004).
- Technical success rates were noninferior between the two groups (94.6% for disposable caps vs. 90.7% for standard scopes; P=.13).
- No significant differences were observed in adverse events or other secondary outcomes between the study groups.
Conclusions:
- Duodenoscopes with disposable elevator caps offer a significant advantage in reducing microbial contamination post-disinfection.
- This design modification enhances the safety of ERCP by minimizing infection transmission risks.
- The use of disposable elevator caps does not compromise the procedural efficacy or safety of ERCP.
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