Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison - 22/01/20
Abstract |
Background and Aims |
Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP.
Methods |
We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes.
Results |
All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P < .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P < .01).
Conclusions |
A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes.
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| DISCLOSURE: Dr Ross reports consulting fees and research funding from Boston Scientific Corporation. Professor Bruno reports consulting and speaker fees and investigator-initiated grants from Boston Scientific Corporation, Cook Medical, Pentax Medical, and 3M; and consultant fees from Mylan. Dr Kozarek reports research support from Boston Scientific Corporation. Dr Petersen reports a consultant/investigator relationship with Boston Scientific Corporation; and consultant fees from Olympus America, Advanced Steriliz Products, and GI Medical. Dr Pleskow reports consultant fees from Boston Scientific Corporation, Olympus, Fuji, Nine Point Medical, and Medtronic. Dr Sejpal reports a consulting/research relationship with Boston Scientific Corporation; and consultant fees from Olympus. Dr Slivka reports research funding from Boston Scientific Corporation and Olympus. Mr Moore and Ms Panduro report consulting relationships with Boston Scientific Corporation. Dr Peetermans, Mr Insull, Mr Rousseau and Mr Tirrell are full-time employees of Boston Scientific Corporation. Dr Muthusamy reports consulting fees and research funding from Boston Scientific Corporation and Medtronic, consultant relationships with Medivators and Interpace, honoraria from Ethicon/Torax, and stockholdership in CapsoVision. Research support for this study was provided by Boston Scientific. |
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| All authors fulfill the International Committee of Medical Journal Editors authorship criteria1 and recommendations in the 2015 Good Publication Practice guideline (GPP3).2 |
Vol 91 - N° 2
P. 396-403 - février 2020 Retour au numéro
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