Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes

Abstract

Introduction: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. Methods: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. Results: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. Conclusions: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Cost-effectiveness Analysis of Single-Use Duodenoscope Applied to Endoscopic Retrograde Cholangiopancreatography

“…A recent publication showed a crossover rate of 9.5% using SUD in 200 ERCPs, 13 although higher crossover rates have been reported because of different technical problems in the course of ERCP performed with SUD. 56 The most common technical problems described were difficulty with the passage into the stomach, image quality, image stability, and air-water button functionality, although the median number of attempts to achieve successful cannulation was lower for SUD versus reusable duodenoscope. 14,56 By contrast, Napoleon et al 57 did not describe any technical issues associated with SUD use.…”

Urgent ERCP performed with single-use duodenoscope (SUD) in patients with moderate-to-severe cholangitis: Single-center prospective study

“…[4][5][6][7] Single use duodenoscopes (SUD) have been recently introduced in clinical practice, hypothesizing that the use of a sterile disposable duodenoscope abolish the risk of patient-to-patient crossinfections. [8][9] Several clinical studies [10][11][12][13][14][15][16][17][18] and two meta-analyses [19,20] confirmed that ERCP procedures performed with SUDs achieve with high cannulation rates, technical performance, and safety profile.…”

Single‐use accessories and endoscopes in the era of sustainability and climate change—A balancing act

“…Multiple studies have confirmed that SUDs are associated with high cannulation rates, technical performance, and safety profile (Table 2). 26,28 20–25,27 A recent systematic review and meta‐analysis analyzed the technical performance and safety of ERCPs using SUDs 28 . The pooled rate of successful cannulation was 95% and sphincterotomy could be successfully performed in all cases.…”