Dataset Information

Equivalent performance of single-use and reusable duodenoscopes in a randomised trial.

ABSTRACT:

Objective

Single-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use and reusable duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).

Design

Patients with native papilla requiring ERCP were randomised to single-use or reusable duodenoscope. Primary outcome was comparing number of attempts to achieve successful cannulation of desired duct. Secondary outcomes were technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events.

Results

98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures. While median number of attempts to achieve successful cannulation was significantly lower for single-use cohort (2 vs 5, p=0.013), ease of passage into stomach (p=0.047), image quality (p<0.001), image stability (p<0.001) and air-water button functionality (p<0.001) were significantly worse. There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts. On multivariate logistic regression analysis, only duodenoscope type (single-use) was associated with less than six attempts to achieve selective cannulation (p=0.012), when adjusted for patient demographics, procedural complexity and type of intervention.

Conclusion

Given the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands.

Trial registration number

Clinicaltrials.gov number: NCT04143698.

SUBMITTER: Bang JY

PROVIDER: S-EPMC8040157 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundApart from conventional reusable bronchoscopes, single-use bronchoscopes (SUB) were recently introduced. Data suggest that SUB might prevent from the risk of cross contamination (i.e. multiresistant pathogens, SARS CoV-2) and save costs. We aimed to investigate visualization, ventilation, handling characteristics, changes in patients' gas exchange, and costs associated with both types of bronchoscopes during percutaneous dilatational tracheostomy (PDT).MethodsIn this prospective, randomized, noninferiority study, 46 patients undergoing PDT were randomized 1:1 to PDT with SUB (Ambu aScope) or reusable bronchoscopes (CONV, Olympus BF-P60). Visualization of tracheal structures rated on 4-point Likert scales was the primary end-point. Furthermore, quality of ventilation, device handling characteristics, changes in the patients' gas exchange, pH values, and costs were assessed.ResultsNoninferiority for visualization (the primary endpoint) was demonstrated for the SUB group. Mean visualization scores (lower values better) were 4.1 (95% confidence intervals: 3.9;4.3) for SUB vs. 4.1 (4.0;4.2) for CONV. Noninferiority of ventilation (estimated by minute volume and SpO2) during the procedure could be shown as well. Mean score was 2.6 (2.0;3.1) for SUB vs. 2.4 (2.1;2.7) for CONV (lower values better). No significant differences regarding handling (SUB: 1.2 (1.0;1.4), CONV: 1.3 (1.1;1.6)), blood gas analyses and respiratory variables were found. Cost analysis in our institution revealed 93 € per conventional bronchoscopy versus 232.50 € with SUB, not considering an estimate for possible infection due to cross-contamination with the reusable device.ConclusionIn our study, visualization and overall performance of the SUB during PDT were noninferior to reusable bronchoscopes. Therefore, PDT with SUB is feasible and should be considered if favored by individual institution's cost analysis.Trial registrationClinicalTrials.gov, NCT03952247 . Submitted for registration on 28/04/2019 and first posted on 16/05/2019.

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Project description:ImportanceInfection 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.ObjectiveTo 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 participantsIn 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.InterventionThe intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design.Main outcomes and measuresCoprimary 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.ResultsFrom 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 relevanceIn 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 registrationClinicalTrials.gov Identifier: NCT04040504.