1. Fast-tracking ERCP learning with the Boškoski-Costamagna Trainer: results of a multicenter randomized clinical trial.
- Author
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Teles de Campos S, Boškoski I, Voiosu T, Salmon M, Costamagna G, Langers A, van Hooft JE, Vanbiervliet G, Gomercic C, Lemmers A, Fockens P, Voermans RP, Barthet M, Gonzalez JM, Laleman W, Tarantino I, Poley JW, de Ridder R, Conchillo JM, Bruno MJ, de Jonge PJF, Devière J, and Arvanitakis M
- Abstract
Background: Achieving competence in endoscopic retrograde cholangiopancreatography (ERCP) requires extensive training. Recognizing the potential of simulator-based education for safe and effective skill development, we aimed to assess whether initial training with the Boškoski-Costamagna ERCP Trainer (BCT) is beneficial compared with conventional training alone (i.e. predictive validity)., Methods: A prospective multicenter randomized trial involving 16 novice ERCP trainees, randomly assigned to intervention or control groups, was performed. Both underwent hands-on training, with the intervention group receiving additional simulation training during the first 3 months. Each trainee was required to complete a minimum of 60 ERCPs in up to 1 year. The TEESAT score evaluated rates of global overall competence (primary outcome), biliary cannulation, and adverse events (AEs; secondary outcomes). Mixed-effect logistic regression models assessed differences in between-group ERCP procedure competence and success. Learning curves were generated cumulatively over the training period., Results: 1106 ERCPs (562 simulator group; 544 control group) were included. Although no statistically significant difference in global overall competence was observed between the groups, possibly owing to data heterogeneity, simulation training demonstrated higher success for native biliary cannulation (52% vs. 42%; P <0.001) and faster median (interquartile range) biliary cannulation times (3 [6] vs. 5 [8] minutes; P <0.001). The simulator group also showed faster improvements in overall performance, native biliary cannulation, and sphincterotomy. No statistical difference was found in overall AEs between the groups., Conclusion: Early simulation training with the BCT improved technical competence in native biliary cannulation and accelerated overall ERCP learning. This approach has the potential to enhance ERCP training programs., Competing Interests: I. Boskoski received a research grant from ERBE Elektromedizin and consultancy fees from Boston Scientific, Cook Medical, Pentax Medical, Siemens, Endotools, Nitinotes, and lecture fees from Microtech; he holds patents USA No. US D740,361 S (Endoscopy Training Apparatus) Oct. 6, 2015 and No. 0001426680, Class A61B1814 (Stent for electrothermal treatment) Feb. 7, 2017, and has stock options from Myka Labs. T. Voiosu has received fees for lectures from Boston Scientific and an educational event from Cook Medical. G. Costamagna has received consultancy fees from Olympus, Waldner Group, and AlfaSigma, as well as speaker's and writer's fees from Malesci. J. Devière’s received institutional support for IRB-approved studies and consultancy fees to his institution from Olympus and Cook Medical, as well as stocks from Endotools Therapeutics. M. Arvanitakis's has received consultancy fees from Olympus and honoraria from Pentax to her institution. J. van Hooft has received lecture fees from Cook Medical, Boston Scientific, Falk, and Fujifilm, and a consultancy fee from Olympus. G. Vanbiervliet has received lecture fees from Norgine, Tillots, Ambu, Fujifilm, and Pentax, and a consultancy fee from Boston Scientific. P. Fockens has provided consultancy for Cook Endoscopy and Olympus. R.P. Voermans received a research grant form Boston Scientific and Prion Medical, and his institution received consultancy fees from Boston Scientific and Cook Medical. J.-M. Gonzalez has received consultancy fees from Fujifilm and Boston Scientific. J.W. Poley has provided consultancy for MediGlobe GmbH, and Pentax Medical. M. Bruno has received consultancy fees from Boston Scientific, Cook Medical, Pentax, and AMBU, support for industry- and investigator-initiated studies from Boston Scientific and Cook Medical, and support for investigator-initiated studies from Pentax Medical, Mylan, AMBU, and ChiRoStim. P.J.F. de Jonge has received consultancy and lecture fees from Boston Scientific, Cook Medical, and Fujifilm. S.T. de Campos, M. Salmon, A. Langers, C. Gomercic, A. Lemmers, M. Barthet, W. Laleman, I. Tarantino, R. de Ridder, and JM Conchillo declare that they have no conflict of interests., (Thieme. All rights reserved.)
- Published
- 2024
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