Face validity of a synthetic papilla designed for biliary sphincterotomy training

Abstract

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is considered one of the most technically demanding endoscopic procedures. Still, limited data are available on simulators in ERCP training. Recently, the Boškoski-Costamagna ERCP Trainer was validated as a realistic training model by our study group. As an extension to this model, a novel synthetic papilla has been designed allowing to train biliary sphincterotomy. We aimed to determine the face validity of this synthetic papilla and its didactic value for training sphincterotomy.

Methods Expert participants, each with more a than 2500 ERCPs lifetime experience, were invited to perform a biliary sphincterotomy and fill out a questionnaire on the realism of the procedure and the didactic value.

Results A total of 40 ERCP experts were included, originating from 16 different countries. Experts’ opinion on realism of performing a biliary sphincterotomy was rated with a median of 7 on a 10-point Likert scale, resemblance of the performed maneuvers 8 and tactile feedback 7. When asked if the cutting was perceived as realistic, experts rated a 6 and the cutting result was rated 8. The potential of the cutting papilla as a training tool for novices was rated 4 on a 4-point scale and there was a high agreement among the experts to include the papilla in the training of novices (rating 4).

Conclusion This is the first synthetic papilla available for training sphincterotomy on the Boškoski-Costamagna ERCP Trainer and it demonstrates good face validity. ERCP experts highly agree on its didactic value and added value in the training curriculum of novice endoscopists.

• References

• 1 van der Wiel SE, Kuttner Magalhaes R, Rocha Goncalves CR. et al. Simulator training in gastrointestinal endoscopy – From basic training to advanced endoscopic procedures. Best Pract Res Clin Gastroenterol 2016; 30: 375-387
• 2 van der Wiel SE, Koch AD, Bruno MJ. Face and construct validity of a novel mechanical ERCP simulator. Endosc Int Open 2018; 6: E758-E765
• 3 Kawai K, Akasaka Y, Murakami K. et al. Endoscopic sphincterotomy of the ampulla of Vater. Gastrointest Endosc 1974; 20: 148-151
• 4 Cotton PB, Lehman G, Vennes J. et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991; 37: 383-393
• 5 Freeman ML, Nelson DB, Sherman S. et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996; 335: 909-918
• 6 Frimberger E, von Delius S, Rosch T. et al. A novel and practicable ERCP training system with simulated fluoroscopy. Endoscopy 2008; 40: 517-520
• 7 Neumann M, Mayer G, Ell C. et al. The Erlangen Endo-Trainer: life-like simulation for diagnostic and interventional endoscopic retrograde cholangiography. Endoscopy 2000; 32: 906-910
• 8 Matthes K, Cohen J. The Neo-Papilla: a new modification of porcine ex vivo simulators for ERCP training (with videos). Gastrointest Endosc 2006; 64: 570-576
• 9 Bar-Meir S. Simbionix simulator. Gastrointest Endosc Clin N Am 2006; 16: 471-478 , vii
• 10 Leung JW, Lee JG, Rojany M. et al. Development of a novel ERCP mechanical simulator. Gastrointest Endosc 2007; 65: 1056-1062
• 11 von Delius S, Thies P, Meining A. et al. Validation of the X-Vision ERCP Training System and technical challenges during early training of sphincterotomy. Clin Gastroenterol Hepatol 2009; 7: 389-396
• 12 Itoi T, Gotoda T, Baron TH. et al. Creation of simulated papillae for endoscopic sphincterotomy and papillectomy training by using in vivo and ex vivo pig model. Gastrointestinal Endoscopy 2013; 77: 793-800
• 13 Bittner JGt, Mellinger JD, Imam T. et al. Face and construct validity of a computer-based virtual reality simulator for ERCP. Gastrointest Endosc 2010; 71: 357-364
• 14 Sahakian AB, Laine L, Jamidar PA. et al. Can a Computerized Simulator Assess Skill Level and Improvement in Performance of ERCP?. Dig Dis Sci 2016; 61: 722-730
• 15 Arnold SH, Svendsen MB, Konge L. et al. Three-dimensional motion tracking correlates with skill level in upper gastrointestinal endoscopy. Endoscopy 2015; 47: 825-828
• 16 Lickert R. A technique for the measurement of attitudes. Arch Psychol 1932; 22: 140-155
• 17 Sedlack R, Petersen B, Binmoeller K. et al. A direct comparison of ERCP teaching models. Gastrointest Endosc 2003; 57: 886-890
• 18 Sedlack RE, Petersen BT, Kolars JC. The impact of a hands-on ERCP workshop on clinical practice. Gastrointest Endosc 2005; 61: 67-71