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DOI: 10.1055/a-2443-6582
Fast-tracking ERCP learning with the Boškoski–Costamagna Trainer: results of a multicenter randomized clinical trial
Supported by: Sociedade Portuguesa De Endoscopia Digestiva Research Grant 2022Clinical Trial: Registration number (trial ID): NCT05533944, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: prospective, multicenter, randomized trial
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.
Publication History
Received: 04 April 2024
Accepted after revision: 06 September 2024
Article published online:
14 November 2024
© 2024. Thieme. All rights reserved.
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References
- 1 Goodman AJ, Melson J, Aslanian HR. et al. Endoscopic simulators. Gastrointest Endosc 2019; 90: 1-12 DOI: 10.1016/j.gie.2018.10.037. (PMID: 31122746)
- 2 Finocchiaro M, Cortegoso Valdivia P, Hernansanz A. et al. Training simulators for gastrointestinal endoscopy: current and future perspectives. Cancers 2021; 13: 1427
- 3 Singh S, Sedlack RE, Cook DA. Effects of simulation-based training in gastrointestinal endoscopy: a systematic review and meta-analysis. Clin Gastroenterol Hepatol 2014; 12: 1611-1623.e4 DOI: 10.1016/j.cgh.2014.01.037. (PMID: 24509241)
- 4 Ekkelenkamp VE, Koch AD, de Man RA. et al. Training and competence assessment in GI endoscopy: a systematic review. Gut 2016; 65: 607-615 DOI: 10.1136/gutjnl-2014-307173. (PMID: 25636697)
- 5 Voiosu T, Puscasu C, Orlandini B. et al. Motion training on a validated mechanical ERCP simulator improves novice endoscopist performance of selective cannulation: a multicenter trial. Endosc Int Open 2021; 09: E145-E151 DOI: 10.1055/a-1315-1994. (PMID: 33532551)
- 6 Wani S, Keswani R, Hall M. et al. A prospective multicenter study evaluating learning curves and competence in endoscopic ultrasound and endoscopic retrograde cholangiopancreatography among advanced endoscopy trainees: the rapid assessment of trainee endoscopy skills study. Clin Gastroenterol Hepatol 2017; 15: 1758-1767.e11
- 7 Wani S, Han S, Simon V. et al. Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees. Gastrointest Endosc 2019; 89: 1160-1168.e9
- 8 Walsh CM, Cohen J, Woods KL. et al. ASGE EndoVators Summit: simulators and the future of endoscopic training. Gastrointest Endosc 2019; 90: 13-26 DOI: 10.1016/j.gie.2018.10.031. (PMID: 31122744)
- 9 Khan R, Scaffidi MA, Grover SC. et al. Simulation in endoscopy: Practical educational strategies to improve learning. World J Gastrointest Endosc 2019; 11: 209-218 DOI: 10.4253/wjge.v11.i3.209. (PMID: 30918586)
- 10 Johnson G, Webster G, Boškoski I. et al. Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy 2021; 53: 1071-1087 DOI: 10.1055/a-1537-8999. (PMID: 34311472)
- 11 Jovanovic I, Fry L, Rustemovic N. et al. Initial validation of a simple, nonbiological, mechanical ERCP training model for cannulation and stent placement. Endoscopy 2015; 47: E585-E586 DOI: 10.1055/s-0034-1393389. (PMID: 26671536)
- 12 Boškoski I, Costamagna G. The Boškoski–Costamagna ERCP Trainer: from dream to reality. Endoscopy 2016; 48: 593-593 DOI: 10.1055/s-0042-103419. (PMID: 27239823)
- 13 van der Wiel S, Koch A, Bruno M. Face and construct validity of a novel mechanical ERCP simulator. Endosc Int Open 2018; 06: E758-E765 DOI: 10.1055/s-0044-101754. (PMID: 29881768)
- 14 Sedlack RE. Validation process for new endoscopy teaching tools. Techniques in Gastrointest Endosc 2011; 13: 151-154
- 15 Bisschops R, Areia M, Coron E. et al. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2016; 48: 843-864 DOI: 10.1055/s-0042-113128. (PMID: 27548885)
- 16 Moher D, Hopewell S, Schulz KF. et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c869-c869 DOI: 10.1136/bmj.c869. (PMID: 20332511)
- 17 Teles De Campos S, Boskoski I, Voiosu T. et al. Face and content validity of a biological papilla designed for the Boškoski-Costamagna ERCP simulator. Gastrointest Endosc 2023; 98: 822-829.e1
- 18 Dumonceau J-M, Kapral C, Aabakken L. et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2020; 52: 127-149 DOI: 10.1055/a-1075-4080. (PMID: 31863440)
- 19 Harris PA, Taylor R, Thielke R. et al. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42: 377-381 DOI: 10.1016/j.jbi.2008.08.010. (PMID: 18929686)
- 20 Harris PA, Taylor R, Minor BL. et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform 2019; 95: 103208 DOI: 10.1016/j.jbi.2019.103208. (PMID: 31078660)
- 21 Lim BS, Leung JW, Lee J. et al. Effect of ERCP Mechanical Simulator (EMS) practice on trainees’ ERCP performance in the early learning period: US multicenter randomized controlled trial. Am J Gastroenterol 2011; 106: 300-306 DOI: 10.1038/ajg.2010.411. (PMID: 20978485)
- 22 Khan R, Homsi H, Gimpaya N. et al. Validity evidence for observational ERCP competency assessment tools: a systematic review. Endoscopy 2023; 55: 847-856 DOI: 10.1055/a-2041-7546. (PMID: 36822219)
- 23 Domagk D, Oppong K, Aabakken L. et al. Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2018; 50: 1116-1127 DOI: 10.1055/a-0749-8767. (PMID: 30340220)
- 24 Voiosu T, Bălănescu P, Voiosu A. et al. Measuring trainee competence in performing endoscopic retrograde cholangiopancreatography: A systematic review of the literature. United European Gastroenterol J 2019; 7: 239-249 DOI: 10.1177/2050640618817110. (PMID: 31080609)
- 25 Meng W, Yue P, Leung JW. et al. Impact of mechanical simulator practice on clinical ERCP performance by novice surgical trainees: a randomized controlled trial. Endoscopy 2020; 52: 1004-1013 DOI: 10.1055/a-1217-6727. (PMID: 32869230)
- 26 Voiosu T, Boskoski I, Voiosu AM. et al. Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial. Endoscopy 2020; 52: 115-122 DOI: 10.1055/a-1049-0359. (PMID: 31766060)
- 27 Voiosu T, Voiosu A, Benguş A. et al. Trainee involvement increases precut rates and delays access to the common bile duct without an increase in procedure-related adverse events: a brave new world of ERCP training?. Rom J Intern Med 2018; 56: 55-61
- 28 Teles de Campos S, Arvanitakis M, Deviere J. A portrait of ERCP and EUS training programs in Europe: current practices and opportunities for improvement. United European Gastroenterol J 2023; 11: 350-360
- 29 Georgiou K, Atliev KT, Oussi N. et al. The use of simulators to acquire ERCP skills: a systematic review. Ann Med Surg 2023; 85: 2924-2931 DOI: 10.1097/MS9.0000000000000819. (PMID: 37363584)
- 30 Liao W-C, Leung J, Wang H-P. et al. Coached practice using ERCP mechanical simulator improves trainees’ ERCP performance: a randomized controlled trial. Endoscopy 2013; 45: 799-805 DOI: 10.1055/s-0033-1344224. (PMID: 23897401)
- 31 Moher D, Hopewell S, Schulz KF. et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c869-c869 DOI: 10.1136/bmj.c869. (PMID: 20332511)