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.

Keywords: endoscopic retrograde pancreatography; therapeutic endoscopy.

Figure 1

The EXALT Model D (Boston scientific Corporation, Marlborough, Massachusetts, USA) single-use duodenoscope with EXALT processor.

Figure 2

Consolidated Standards of Reporting Trials flow diagram of patients recruited for participation in the randomised trial.

Figure 3

(A) Single-use duodenoscope enface to the major duodenal papilla on endoscopic view. (B) Endoscopic image showing the position of the single-use duodenoscope in relation to the major papilla and (C) the corresponding fluoroscopic image. (D) Bile duct stone extraction via the major duodenal papilla as seen on endoscopic view and (E) the corresponding fluoroscopic image (note the relatively straight-scope position).