Hands-on simulation practice for training ERCP assistants

J Interv Gastroenterol 4:4, 94-99; October/November/December 2014; 2014 Journal of Interventional Gastroenterology Hands-on simulation practice for training ERCP assistants Joseph W. Leung 1,2, Andrew W. Yen 1,2, Dannie Prather 1, Christie Opada 1, Jaymie Pearcy 1, Rebeck Gutierrez 1, Mary Claire Reyes- Galzote 1, Felix W. Leung 3 1 Section of Gastroenterology, Sacramento Veterans Affairs Medical Center, Veterans Affairs Northern California Healthcare System, Mather, CA, USA; 2 University of California, Davis Medical Center, Sacramento, CA, USA; 3 Research and Medical Services, Sepulveda Ambulatory Care Center Sepulveda, Veterans Affairs Greater Los Angeles Healthcare System and David Geffen School of Medicine at UCLA, Los Angeles, CA, USA Key words: GI assistant, ERCP, simulation training Abbreviations: ERCP, endoscopic retrograde cholangiopancreatography; GI, gastrointestinal; EMS, ERCP mechanical simulator; MS, mechanical simulator; RN, registered nurses; LVN, licensed vocational nurse; MRCP, magnetic resonance cholangiopancreatography Introduction: Successful endoscopic retrograde cholangiopancreatography (ERCP) requires close coordination between the endoscopist and the assistant. The ability of the assistant to handle a wide range of accessories efficiently facilitates timely completion of the procedure. We attempted to determine the acceptance of didactic teaching/discussions combined with hands-on simulation practice of ERCP by gastrointestinal (GI) assistants. We tested the hypothesis that simulation practice with accessories will be perceived by GI assistants as a credible modality to facilitate learning of ERCP techniques and for gaining familiarity with the operation of new accessories. Method: This study is an analysis of prospectively collected survey data during ERCP training workshops (ABC s of ERCP) designed specifically for GI assistants. GI assistants participated in ERCP training workshops at the Sacramento VA Medical Center over a 5-year period. They attended a series of didactic talks on different aspects of ERCP practice, followed by 4 hour small group hands-on simulation practice sessions with different ERCP accessories. Participants responded to a survey of their ERCP experience and completed pre- and post- practice evaluations on their acceptance of simulation practice. Results: 282 GI assistants (nurses and technicians) attended 8 hands-on training workshops. There was a significant increase in all evaluation parameters, indicating that GI assistants find the workshops useful in improving their knowledge and practice skills. Conclusions: The favorable assessment after hands-on simulation practice indicates endorsement of this mode of training by GI assistants. However, the clinical benefits of GI assistants receiving simulation training remain unknown. Introduction Endoscopic retrograde cholangiopancreatography (ERCP) is a complex and technically demanding procedure. Favorable outcomes depend on the skill of the endoscopist as well as efficient coordination between the endoscopist and the assistant. 1 Most gastrointestinal (GI) assistants (nurses or technicians) learn to assist ERCP as part of on-the-job training. We previously described favorable evaluations by GI fellows who received hands-on simulation practice using an ERCP mechanical simulator (EMS). 2 The impact of hands-on simulation practice on GI assistants to improve their role in assisting ERCP is unknown. In this study, we evaluated the acceptance of didactic discussions combined with hands-on simulation practice by GI assistants who participated in organized training workshops. We tested the hypothesis that GI assistants will perceive simulation practice as a credible method to *Correspondence to: Joseph W. Leung; Email: jwleung@ucdavis.edu Submitted: Aug/26/2014; Revised: Sep/20/2014; Accepted: Sep/25/2014 DOI: 10.7178/jig.169 facilitate learning of ERCP techniques and accessories. Materials and method The mechanical simulator The mechanical simulator (MS) consisted of a simulated endoscope and a mechanical duodenum. The shaft of the simulated endoscope is made of a 3½ feet long and ½ inch diameter hose. It has no elevator or endoscope tip controls. A side arm adaptor is fitted with a biopsy valve to resemble the instrument channel. The end of the simulated endoscope is attached to the simulated mechanical duodenum. In addition, artificial bile ducts of different design are made from Tygon tubes, and these can be attached to the mechanical duodenum. This simulation set up is used to practice wire exchange, manipulation of balloon or stone extraction baskets and biliary stent placement. This set up allows the assistant to handle real accessories and perform coordinated exchange of ERCP accessories. The transparent (Tygon) bile duct allows the assistant to observe events inside the bile duct and facilitates manipulation of accessories without the need for 94 J Interv Gastroenterol Volume 4 Issue 4

Research paper ORIGINAL PAPER Figure 1. The mechanical simulator (close up view) showing the simulated endoscope with wire lock, the mechanical duodenum and setup for a stenting practice Figure 2. Mechanical simulators mounted on gurneys for group teaching fluoroscopy (Fig. 1). In contrast to the EMS, hands-on practice does not require the use of real endoscopes. 2-4 Such simulation practice can also be conducted without an endoscopist or endoscopy setup, thus allowing flexibility in practice training. The teaching workshop ABC s of ERCP This annual workshop consisted of two parts. It began with a half-day lecture series including 8 didactic talks covering different aspects of ERCP from organization of the ERCP room, role of the GI assistant in ERCP and introduction to basic ERCP techniques such as cannulation, papillotomy, stone extraction, balloon dilation, brush cytology and stenting (Table 1). This was followed by a half-day of hands-on simulation practice using mechanical simulators and different ERCP accessories (Fig. 2). The participants were divided into small groups of 3 and rotated through 10 practice stations focused on different ERCP accessories, including one station on endoscope reprocessing. Each practice station lasted 25-30 minutes. Each group was led by an instructor who demonstrated operation of different accessories with emphasis on coordinated exchanges. The participants then repeated the maneuvers on the simulator. Hands-on practice included insertion of a catheter or papillotome, exchange over a guide wire, manipulation of a stone extraction balloon and basket, use of pressure insufflator for balloon dilation, brush cytology of a simulated bile duct stricture and placement of a plastic biliary stent. In addition, participants were introduced to short wire technology for stenting and performance of mechanical lithotripsy (Table 2). Participants completed pre-workshop surveys on their ERCP experience and their acceptance of this format of simulation training. 2,5 Specifically, participants were asked to respond to a set of pre- and post- practice expectation questions (on a 10 point scale) which included (Table 3): (1) How logical does this simulator practice seem to you? (2) How confident are you that this simulation practice would be successful in improving your skills in assisting ERCP? (3) How confident would you be in recommending simulation practice to colleagues who are learning to assist ERCP? (4) Would you be willing to undergo proposed simulation training for improving your skills in assisting ERCP? (5) How successful do you feel this type of simulation practice would be in enhancing the skills of assisting a different endoscopic procedure, e.g. esophageal stenting? The summation of responses to these questions constituted the credibility score. 2 In addition, participants also responded to pre- and postpractice questionnaires on their understanding of the different ERCP techniques and their confidence in assisting with such procedures using a 5 point scale (5=very knowledgeable/confident, 1=none) (Table 4). Data analysis Data were tabulated as mean±sd. The pre- and post-workshop understanding and confidence scores and credibility scores were compared using paired t test. All analyses were two-sided. Data analysis was performed using Stata version 10.0 (Stata Corp, College Station, TX). Further comparison was made in the pre and post-practice evaluations by the different groups of participants using the ANOVA test with p<0.05 being significant. Results Over a 5-year period from 2009 to 2013, a total of 282 GI assistants attended 8 training workshops. The majority of participants (>80%) were registered nurses (RNs); with the remaining consisting of licensed vocational nurses (LVNs); technicians and other professionals. Approximately 56% of participants worked in community hospitals, 16% in university hospitals, 16% in ambulatory surgery centers and 12% in VA hospitals. Most of the participants worked in hospitals that regularly performed ERCP procedures. Some participants were referred to the course by their nursing managers for introductory training in ERCP to prepare www.jigjournal.org J Interv Gastroenterol 95

Table 1. Topics for didactic talks during ERCP training workshop 1. Organization of the ERCP room 2. Role of GI assistants in ERCP 3. Interpretation of ERCP films 4. Selective cannulation 5. Papillotomy 6. Stone extraction 7. Dilation and brush cytology 8. Biliary stents Table 2. Simulated ERCP procedures during hands-on simulation practice 1. Introduction to catheters, papillotome 2. Practice exchange of guide wires 3. Balloon stone extraction 4. Basket stone extraction 5. Balloon dilation and brush cytology of bile duct stricture 6. Plastic biliary stents 7. Short wire stenting technologies 8. V- system and V scope 9. Mechanical lithotripsy 10. Scope reprocessing Table 3. Pre- and Post- practice questionnaire on expectation (Credibility score): (To be completed before and after hands-on simulator practice on a scale of 1 to 10) 1. How logical does this type of simulator practice seem to you? (1=not logical; 10=logical) 2. How confident would you be that this simulator practice would be successful in improving your ERCP skills in assisting with ERCP? (1=not confident; 10=confident) 3. How confident would you be in recommending simulator practice to colleagues who are learning to assist with ERCP? (1=not confident; 10=confident) 4. Would you be willing to undergo proposed simulator training for improving your skills in assisting with ERCP? (1=not willing; 10=willing) 5. How successful do you feel this type of simulator practice would be in enhancing the skills of assisting with a different endoscopic procedure (e.g. esophageal stenting? (1 = not successful; 10 = successful) Table 4. Pre- and Post- practice evaluation (To be completed before and after the didactic talks and hands-on simulator practice) Rate your response to the following (5=very knowledgeable/confident, 1=none): Basic ERCP skills: Understanding Confidence in assisting Organization of the ERCP Room 5 4 3 2 1 5 4 3 2 1 Role of GI Assistants in ERCP 5 4 3 2 1 5 4 3 2 1 Interpretation of ERCP films 5 4 3 2 1 5 4 3 2 1 Selective Cannulation 5 4 3 2 1 5 4 3 2 1 Papillotomy 5 4 3 2 1 5 4 3 2 1 Stone Extraction 5 4 3 2 1 5 4 3 2 1 Dilation and Brush Cytology 5 4 3 2 1 5 4 3 2 1 Biliary Stents 5 4 3 2 1 5 4 3 2 1 Advanced ERCP skills and new techniques: Understanding Confidence in assisting Mechanical Lithotripsy 5 4 3 2 1 5 4 3 2 1 Fusion 5 4 3 2 1 5 4 3 2 1 V-Scope/ V-System 5 4 3 2 1 5 4 3 2 1 Rapid Exchange 5 4 3 2 1 5 4 3 2 1 them for off-hour emergency procedures. Out of the 282 participants, pre- and post- workshop surveys on attendees understanding of ERCP and their confidence in assisting ERCP were obtained from 210 and 204 participants, respectively. Of these, completed sets of responses were received from 176 (84%) and 158 (77%), respectively, and the results were compared. Incomplete sets of responses were due to either missing pre- or post-evaluations. Overall analysis showed a significant increase in the understanding of ERCP and improved confidence in assisting ERCP after the workshop (Table 5 and 6). Two hundred forty of 282 participants completed both preand post-practice evaluations on their acceptance of simulation practice for ERCP training. There was a significant increase in the mean total credibility score (p<0.05, paired t test) (Table 7). Assistants believed that simulation practice was logical; they were confident that it would improve their skills in assisting ERCPs; and they would recommend the training to other GI assistants. There was also significant difference in willingness to participate in simulation training despite the already high baseline pre-training score (9.4; p<0.05) which was likely influenced by a motivated group of attendees as approximately 10% were returning participants, and also many new participants were referred by nursing managers to gain more ERCP experience. There were no significant differences between assessments by 96 J Interv Gastroenterol Volume 4 Issue 4

Table 5. Understanding of ERCP procedures (n=176) Pre value Post value p Organization 3.83 (1.20) 4.54 (0.78) <0.05 Role of Assistant 3.79 (1.21) 4.54 (0.76) <0.05 X-ray interpretation 2.83 (1.23) 3.88 (1.04) <0.05 Selective cannulation 3.05 (1.32) 4.14 (0.96) <0.05 Sphincterotomy 3.32 (1.32) 4.24 (0.93) <0.05 Stone extraction 3.27 (1.31) 4.28 (0.86) <0.05 Lithotripsy 2.99 (1.36) 4.18 (0.93) <0.05 Dilation and brush cytology 3.20 (1.31) 4.27 (0.87) <0.05 Plastic & metal stents 3.11 (1.27) 4.23 (0.88) <0.05 Short wire technology 2.92 (1.28) 4.14 (1.04) <0.05 Fusion system 2.49 (1.39) 3.74 (1.13) <0.05 V scope/v system 2.22 (1.38) 3.59 (1.19) <0.05 Rapid exchange system 2.59 (1.38) 3.66 (1.19) <0.05 Overall 3.13 (1.37) 4.15 (0.99) <0.05 Mean (SD), p<0.05 is significant, paired t test. Table 6. Confidence in assisting with ERCP procedure (n=158) Pre value Post value p Organization 3.30 (1.21) 4.05 (1.08) <0.05 Role of Assistant 3.07 (1.38) 3.95 (1.14) <0.05 X-ray interpretation 2.44 (1.17) 3.37 (1.13) <0.05 Selective cannulation 2.60 (1.28) 3.57 (1.14) <0.05 Sphincterotomy 2.72 (1.34) 3.64 (1.16) <0.05 Stone extraction 2.68 (1.35) 3.66 (1.13) <0.05 Lithotripsy 2.32 (1.21) 3.48 (1.14) <0.05 Dilation and brush cytology 2.59 (1.35) 3.65 (1.11) <0.05 Plastic & metal stents 2.47 (1.28) 3.58 (1.09) <0.05 Short wire technology 2.46 (1.27) 3.51 (1.04) <0.05 Fusion system 2.13 (1.29) 3.32 (1.20) <0.05 V scope/v system 1.93 (1.23) 3.17 (1.30) <0.05 Rapid exchange system 2.23 (1.30) 3.30 (1.24) <0.05 Overall 2.57 (1.34) 3.58 (1.17) <0.05 Mean (SD), p<0.05 is significant, paired t test. Table 7. Credibility score of simulation practice for ERCP training (n=240) Questions on use of mechanical simulator for ERCP training Pre score, Mean (SD) Post score, Mean (SD) p How logical is simulation training for ERCP 9.18 (1.44) 9.62 (0.80) <0.05 Confidence in improving ERCP skill 8.83 (1.75) 9.29 (1.24) <0.05 Recommendation to colleague for ERCP training 9.13 (1.45) 9.64 (0.86) <0.05 Willingness to undergo further ERCP training with simulator 9.48 (1.21) 9.72 (0.68) <0.05 Success in using simulator for other endoscopy techniques 9.03 (1.63) 9.45 (1.14) <0.05 Total score 45.2 (7.30) 47.7 (3.89) <0.05 Mean (SD), p<0.05 is significant, paired t test. the different groups of GI assistants, except in the recommendation to others after simulation practice by the registered nurses and technicians compared to the other groups. Discussion A successful ERCP requires coordination between endoscopist and assistant. An experienced assistant should have the basic knowledge (cognitive) and (technical) skills to assist with manipulation/ exchange of accessories, ensuring a smooth and efficient service. A well-coordinated team is important for providing quality service and ensuring patient safety. 6 In the United States, GI assistants are expected to possess basic ERCP skills through training before they are allowed to assist with ERCP procedures. 7,8 Such training includes basic knowledge of ERCP including room setup and how to operate www.jigjournal.org J Interv Gastroenterol 97

different equipment and accessories. Assistants should be able to handle a wide range of accessories and possess the skills to assist with manipulation and exchange of these accessories in close coordination with the endoscopist. 9 The availability of training opportunities and level of experience varies by institution. Indeed, many GI assistants are self-trained or learn by observing their colleagues before gaining hands-on experience. 10 While vendors can explain how devices should be operated, actual hands-on clinical experience can only be gained on a patient. The decrease in utilization of diagnostic ERCP following the advent of non-invasive imaging such as magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasonography (EUS) has reduced clinical learning opportunities for trainee endoscopists. 11,12 There is a trend in favor of extending advanced ERCP training to a 4 th year fellowship 13 in order for trainees to acquire sufficient experience. Similarly, there is a corresponding emphasis on qualifications of the assistant. 10 Some institutions have a special team of GI nurses assisting with complex procedures while others only have nurses that fill-in whenever cases are available. Endoscopists have commented on the advantage of having a dedicated team of experienced GI assistants rather than working with an ad hoc team where experience can be quite variable. Off hour and on call coverage for ERCP at their home institution was a motivating factor for participants to attend the training workshop. Participants, particularly those who had just joined the GI unit at their hospital, felt more comfortable in assisting with these cases knowing that they had some understanding of ERCP and their role as an assistant. Those who are expected to be trained and to assist with ERCP procedures in the community setting namely the registered nurses and technicians found the simulation practice especially beneficial and were more willing to recommend the training to other colleagues. ERCP procedures require active participation by the assistants in performing contrast injection, manipulation of the guide wire in selective cannulation and accessories exchange. A prior study suggested that inexperienced assistants tended to inject contrast at a much higher pressure than experienced assistants. 14 This could be corrected quickly by feedback training. In addition to excess contrast injection, repeat insertion of a guide wire into the pancreas during selective bile duct cannulation may also increase the risks of post-ercp pancreatitis. 15 Error or lack of coordination, e.g. losing wire access during exchange of accessories, could prolong an ERCP procedure. Adequate training of both endoscopist and assistant to become proficient with coordinated exchange may prevent unwanted complications. The current literature has few reports on the results of formal assistants training, but training opportunities are available, e.g. the Olympus University special courses 16 and other ERCP training programs such as ours, all of which emphasize the need for handson practice. Although ERCP is technically challenging, many of these procedures involve similar but repetitive maneuvers. Good coordination demands experience on the part of the assistant to properly control the accessories. However, clinical learning and practice opportunities are still limited for GI assistants. We have organized multiple teaching workshops for GI assistants in Northern California over the past 10 years. We provided didactic teaching and practice opportunities to handle different ERCP accessories using a simple mechanical simulator. The didactic sessions covered the basics of ERCP including interpretation of x-rays and different techniques to improve assistants understanding and skills in ERCP procedures. Several simulator models are available for teaching and learning ERCP, including computer simulators, 17 ex-vivo organ models such as the Erlangen Endotrainer, 4 the anesthetized pig model 3 and the ERCP mechanical simulator. 2 All of these training models provide the endoscopist and assistant with the opportunity to practice different techniques. Computer simulators, however, lack the use of real accessories and may not be a useful training tool for assistants. When assisting with an ERCP procedure, what most assistants need to understand is controlled manipulation of the accessories which can be learned without a real endoscope or presence of an endoscopist. It is important to train the assistant to stay focused in control of the device (e.g. opening and closing a basket), manipulation of a guide wire (as in selective cannulation) and coordinated exchange of accessories (as in stenting). In our experience, the mechanical simulator is simple, inexpensive and enables a relatively large group of assistants to undergo training while keeping a small number of participants at each station to allow ample time for practice. The mechanical simulator practice also provides assistants with opportunities to learn new ERCP techniques and familiarize themselves with accessories before using them in the clinical setting. Mechanical simulator training does not alter the need for sedation for ERCP, but it may shorten the procedure time (by minimizing the need for on-the-job training) and in turn, decrease the amount of sedation medications administered because of improved team efficiency. The results from this study show that assistants value these learning opportunities and endorse this format of training as evidenced by the significant increase in the post- practice credibility scores as well as understanding and confidence scores. Acknowledgement Supported in part by Veterans Affairs Medical Research Funds, Clinical Research Award of the American College of Gastroenterology (JWL) and the C.W. Law Research Fund (JWL). The hands-on ABCs of ERCP workshops received educational support from Cook Medical and Olympus America. The authors are indebted to the many instructors who participated in the workshops. A special thanks to Mr. Robert Wilson who made the mechanical simulators for ERCP practice. References 1. Leung J. Fundamentals of ERCP in Advanced Digestive Endoscopy: ERCP, Edited by Cotton and Leung. Published by Blackwell Publishing, 2005:17-79. 2. Leung JW, Lee J, Rojany M, Wilson R, Leung FW. Development of a Novel ERCP Mechanical Simulator. Gastrointest Endosc 2007; 65:1056-62. 3. Cohen J. Training and credentialing in gastrointestinal endoscopy in endoscopy practice and safety, in Cotton Ed. Advanced endoscopy e-book, www.gastrohep.com 2005:1-50. 4. Sedlack R, Petersen B, Binmoeller K, Kolars J. A direct comparison of ERCP teaching models. Gastrointest Endosc 2003; 57:886-90. 5. Borkovec TD, Nau SD. Credibility of analogue therapy rationales. J Behav Ther Exp Psychiatry 1972; 3:257-60. 6. Malpas P. Staffing the ERCP team. In Cotton and Leung Edition of Fundamentals of ERCP (Chapter 3). Published by Wiley, 2015 (in press). 98 J Interv Gastroenterol Volume 4 Issue 4

7. New Jersey Board of Nursing. (June 1999) Fact Sheet: Decision Making Model for Determining Scope of Nursing Practice. Retrieved February 5, 2008 from www.state. nj.us/lps/ca/nursing/algo1.htm 8. Day ME, JuanM, Friis CM, Hart L, Herrin A, LindsayJ, et al. Role Delineation of the Registered Nurse in a Staff Position in Gastroenterology. Position statement published by the SGNA 2012. 9. Lail L, Cotton PB. Risks of endoscopic retrograde cholangiopancreatography and therapeutic applications. Gastroenterol Nurs 1990; 12:239-45. 10. Zuccala B. ENDD05-1207: Achieving Competency in ERCP. EndoNurse Institute. Retrieved February 5, 2008 from www.endonurseinstitute.com/home/htm 11. Mazen Jamal M, Yoon EJ, Saadi A, Sy TY, Hashemzadeh M. Trends in the utilization of endoscopic retrograde cholangiopancreatography (ERCP) in the United States. Am J Gastroenterol 2007; 102:966-75. 12. Simmons DT, Baron TH. perceptions on ERCP utilization in the United States. Am J Gastroenterol 2007; 102:976-7. 13. Guidelines for advanced endoscopy training. The American Society for Gastrointest Endosc, 2006. http://www.asge.org//pages/education/training/advanced.cfm 14. Mathews JS, Maher KA, Cattau EL Jr. The role of endoscopic retrograde cholangiopancreatography injection training sessions for the gastroenterology nurse and associate. Gastroenterol Nurs 1989; 12:106-8. 15. Vandervoort J, Soetikno RM, Tham TC, Wong RC, Ferrari AP Jr, Montes H, et al. Risk factors for complications after performance of ERCP. Gastrointest Endosc 2002; 56:652-6. 16. EUS/ERCP Nurse seminar. Olympus University, Olympus America. Retrieved February 5, 2008 from www.olympusamerica.com/olympus univeristy /ou_eus.asp. 17. Bar-Meir S. Simbionix simulator. Gastrointest Endosc Clin N Am 2006; 16:471-8, vii. www.jigjournal.org J Interv Gastroenterol 99