The European experience—current use of simulator training in Europe

Techniques in Gastrointestinal Endoscopy (2011) 13, 126-131

Techniques in GASTROINTESTINAL ENDOSCOPY www.techgiendoscopy.com

The European experience— current use of simulator training in Europe Juergen Maiss, MD,a Andreas Naegel, MD,b Juergen Hochberger, MDc aGastroenterology

Clinic Dr Kerzel/PD Dr Maiss, Forchheim, Germany. of Medicine, University Erlangen-Nürnberg, Erlangen, Germany. cDepartment of Medicine III, St Bernward Hospital, Hildesheim, Germany. bDepartment

KEYWORDS: Endoscopy; Endoscopy training; Training; Further education; Simulator training; Endoscopy simulators

Diagnostic and interventional endoscopy has undergone an enormous evolution and refinement in the past 2 decades. Consequently, the requirement of skill sets for endoscopists increased and a need for training and education have become clear. Since the mid-1990s, different training simulators have been developed. This article describes the status of endoscopy training in Europe and the current use of simulators in various European countries. Several working groups have developed and established various simulators and training platforms for nearly all diagnostic and interventional techniques. Therefore, the availability of different training simulators is not unexpected in most European countries. © 2011 Elsevier Inc. All rights reserved.

Endoscopy underwent a tremendous development in the past 2 decades and often replaced surgical procedures, even in patients with malignant disease. In particular, the expansion of interventional techniques, for example, endoscopic submucosal dissection (ESD), led to enhanced requirements of skills from the endoscopist. An endoscopist needs several years of practical training and continuous refinement of his or her theoretic knowledge and manual skills.1,2 Various working groups started in the 1990s to improve training practices by developing new simulator platforms.3 Until 1990, only plastic phantoms existed, which allowed the training of only basic manual skills in diagnostic endoscopy.4 In the meantime, a number of simulators were developed (Table 1) and nearly all diagnostic and interventional endoscopic procedures can be simulated and trained.5-14 Even for Natural Orifice Transluminal Endoscopic Surgery (NOTES), simulators like the EASIE-R simulator (EndoSim LLC, Berlin, MA) or the ELITE system (CLA, Coburg, Germany) were presented and pilot studies were conducted.15,16

The authors report no direct financial interests that might pose a conflict of interest in connection with the submitted manuscript. Address reprint requests to Juergen Maiss, MD, Gastroenterology Clinic Dr Kerzel/PD Dr Maiss, Mozartstrasse 1, D-91301 Forchheim, Germany. E-mail: [email protected] or [email protected] 1096-2883/11/$-see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.tgie.2011.02.008

Although a variety of simulation systems exist and the need for training is clear, standardized obligatory training programs have not been introduced into the endoscopic education in comparison with the training for ultrasonography in Germany (in nearly all European countries ultrasound is performed by physicians), where a structured education by accredited ultrasound tutors and training courses are mandatory to achieve graduation for ultrasound. Therefore, endoscopic newcomers often must rely on the policy “learning by doing” under the supervision of an experienced colleague, usually from the same endoscopy department.2 We present an overview of the current use of simulator training in Europe.

Available training simulators First, we will describe the currently available endoscopy simulators in Europe (Table 1). The first training simulator was the plastic phantom developed by Classen and Ruppin in 1974.4 This type of simulator is still in use at some hospitals. Additionally, manufacturers of endoscopes lend these plastic phantoms for upper gastrointestinal (GI) endoscopy or the Koken colonoscopy simulation model (Colonoscopy Training Model-I-B, Koken Co, Ltd, Tokyo, Japan) for training of basic skills in lower GI endoscopy. By far the most advanced static simulator is the Interphant

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Table 1

Endoscopy simulators used for training in Europe5-14

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Simulator type

Simulator name

Simulation possibilities

Availability

Static simulators

GI-Phantom Classen and Ruppin Koken colonoscopy simulator Tübingen Interphant model

Diagnostic upper GI endoscopy Diagnostic lower GI endoscopy Diagnostic and interventional upper and lower GI endoscopy NOTES simulation Various ERCP procedures Diagnostic and partly interventional upper and lower GI endoscopy Diagnostic and partly interventional upper and lower GI endoscopy Diagnostic lower GI endoscopy Diagnostic and all interventional upper GI endoscopy; enteroscopy and doubleballoon ERCP Diagnostic and all interventional upper and lower GI endoscopy; enteroscopy and double-balloon ERCP Diagnostic and all interventional lower GI endoscopy and proctoscopy All diagnostic and interventional upper and lower GI procedures, including double-balloon enteroscopy and NOTES procedures Diagnostic and interventional diagnostic upper GI endoscopy NOTES procedures

All over Europe All over Europe Germany

Computer simulators

ELITE system X-Vision ERCP training system Simbionix GI-Mentor CAE AccuTouch

Animal part simulators

Olympus colonoscopy simulator compactEASIE

Erlangen Endo-Trainer

coloEASIE EASIE-R

Narcotized animals

Pigs

model developed by Grund et al from Tubingen, Germany.17 The Interphant model, in contrast to all other plastic phantoms or static models, allows most interventional techniques.17 This model is currently used at endoscopy courses in Germany but is not commercially available. In 2008, a new endoscopic retrograde cholangiopancreatography (ERCP) simulation model, the X-Vision ERCP simulation system, which allows ERCP and sphincterotomy without fluoroscopy, was presented by another German group. It is a static simulator made of plastic. The artificial biliary system can be seen through a glass panel. A conductive material is used for the papilla, which allows electrosurgical manipulation.8,18 At the end of the 1990s, virtual reality widened the spectrum of endoscopy simulators. Recently, the Simbionix GI-Mentor (Simbionix USA Corp, Cleveland, OH),5 the AccuTouch system19 from Immersion Medical Corporation now distributed by CAE (CAE, Montreal, Canada), and the Olympus Endo TS-1 colonoscopy simulator (Olympus KeyMed, Southend, UK) became available.9 The GI-Mentor as well as the AccuTouch can simulate some interventions, such as sclerotherapy, polypectomy, and sphincterotomy, in a virtual reality environment.20 Special computer instruments are used but they differ from real accessories. Additionally, a module for endoscopic ultrasound exists for the Simbionix GI-Mentor.20 Some centers in Europe use these computer simulators for training purposes.

Germany Germany All over Europe All over Europe In studies All over Europe

All over Europe

All over Europe All over Europe

In special training centers in Europe

At the moment, the largest variety of simulation possibilities is warranted by ex vivo animal model simulators or biosimulation models.2,3,21-23 They can be used in all steps of the educational pyramid described by Hochberger and colleagues.2 Biosimulation models can be summarized in simulators using organs of animals, which are usually obtained fresh from a slaughterhouse. This kind of simulation is common for training in surgical disciplines such as laparoscopic abdominal and thoracic surgery, gynecology, urology, ear, nose, and throat, and orthopedics. Freys et al reported first in 1995 on the use of a pig stomach for teaching diagnostic gastroscopy.24 In 1996, Hochberger and Neumann developed a new simulator, the Active Simulator for Interventional Endoscopy (EASIE), for the simulation of interventional endoscopy. In 1997, the EASIE concept of training and teaching in interventional upper GI endoscopy on specially prepared porcine upper GI organ packages was developed by Hochberger, Maiss, and Euler, which included 1-day training courses for doctors and nurses on different topics like endoscopic hemostasis, ERCP, and polypectomy.10 More than 30 different interventional techniques can be practiced in the upper GI tract and hepatobiliary system.2 This system is currently available as the EASIE or the Erlangen Endo-Trainer all over Europe in different courses.23,25 Recently, the EASIE simulator was refined by Matthes et al and they presented the EASIE-R

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model, which is now also suitable for the training of NOTES procedures.26-28 Finally, narcotized pigs and dogs especially have been used for ERCP techniques.29-31 Major advantages of training on in vivo models are the natural tissue feeling, elasticity, and tactile feedback of organ structures, which are similar to that in humans. Ethical aspects, protection of animals, and a large personal and financial expenditure are major restrictions and most techniques can be trained using less expensive animal part simulators. Nevertheless, the NOTES development revived the use of narcotized animal—mostly pigs—for studies as well as for training. In Europe, different centers were established for surgical training like Ethicon in Norderstedt, Germany, Aesculapium in Tuttlingen, Germany, or IRCAD in Strassbourg, France, which are now also active in training and research of NOTES techniques.

Studies on endoscopic training Since 2000, the literature on endoscopic training has increased remarkably. A PubMed search using the terms “simulator,” “training,” and “endoscopy” generated 523 hits. Many of these papers are derived from laparoscopic surgery. Most of these articles (n ⫽ 482) were published after the year 2000. To specify the results, we used the terms “simulator,” “training,” and “colonoscopy” and identified 53 publications about training in colonoscopy. Compared with the importance of the topic, the number of papers is low compared with the number of publications regarding NOTES in the same period. All publications but 1 were published after the year 2000 and concentrated on the validation of computer simulators or skills assessment. Most studies were conducted in Europe (n ⫽ 27), which reflects increasing efforts in improving endoscopic education in European countries. Most studies focused on construct validity and demonstrated that computer simulators like the GI-Mentor or the AccuTouch simulator mostly improve basic skills in colonoscopy.32-34 For upper GI endoscopy the situation is more difficult. A PubMed search using the terms “simulator,” “training,” “EGD,” or “gastroscopy” identified just 3 publications, with only 1 being from Europe.7 Clinical prospective trials on diagnostic gastroscopy are even more infrequent. There is only 1 trial that is published as an abstract.35 This prospective randomized trial from our working group compared 3 training strategies in gastroscopy. The first group had only clinical training, the second group received only simulator training, and the third group received clinical and simulator training over a period of 4 months. At the end of the training, each trainee was evaluated blindly on 3 in vivo patient cases. The group with combined clinical and simulator training tended to be somewhat faster than the other groups and had better performance skills. Our group concluded that clinical education accompanied by structured simulator training appeared to be the best way to teach diagnostic gastroscopy.35 Simulator training alone seems

insufficient to improve skills in clinical diagnostic upper GI endoscopy. The feedback of an experienced tutor is especially important, as demonstrated for computer simulators.12,35 For training of interventional endoscopy, only a few studies exist. Most studies concentrated on ERCP or hemostasis.13,14,20,22,25,36-40 The studies on simulator training in hemostasis employed an ex vivo simulator and were initiated in Europe by our working group.22,36,39 Only this simulator type could simulate a spurting or oozing bleeding in a close-to-life setting. There were 2 prospective, randomized, and controlled long-term studies, 1 in New York and 1 in France.36,39 Both studies demonstrated that additional simulator training in 4 different endoscopic hemostatic techniques (clipping, injection, coagulation, and variceal band ligation) led to a significant increase in skills for the simulator-trained group in comparison with the control group with standard education at the home institution. Also, in the following clinical cases the simulator-trained group had a significantly better patient outcome than the solely clinically trained group.36,39 For the first time, an objective benefit for additional training in interventional endoscopy was demonstrated. This first 7-month trial was conducted in New York City as a collaborative effort of the New York Society of Gastrointestinal Endoscopy and the Friedrich-AlexanderUniversity of Erlangen, Germany.36 The educational as well as the clinical system in the United States is different from that of most European countries. Therefore, the suggestion was made to conduct a comparable trial in Europe. In 2001, a long-term training project over a period of 9 months was conducted in the same hemostasis techniques as the National Project in France organized by the French National Endoscopy Society (Société Française D’Endoscopie Digestive) in conjunction with the Friedrich-Alexander-University of Erlangen, Germany. The findings of the prior study were confirmed in this trial. Therefore, the simulator training effects were independent of health care or medical training and educational system.39 A separate analysis of both trials demonstrated that some techniques required repetitive training (eg, clipping, injection, and coagulation), whereas variceal band ligation could be trained sufficiently in a single 1-day training course.25 ERCP can be trained in static computer and ex vivo animal simulators.3,8,11,14,20 Most studies focused on the feasibility and validation of the simulators.14,18,40,41 Only 1 study prospectively investigated the use of a mechanical simulator compared with clinical education in ERCP and described a significantly higher biliary cannulation success and reduced cannulation times of trainees with simulator experience.38 In 2002, an expert group evaluated different simulation models (EASIE, live pigs, GI-Mentor computer simulator) for ERCP training. Each simulator was proven to be an effective training model but animal ex vivo simulators were felt to be the most realistic and favorable teaching tool.40 To overcome some anatomic problems of this simulator type, Matthes et al developed the Neopapilla model, which allowed both pancreatic and biliary tract instrumen-

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tation in an artificial papilla made of chicken heart tissue overcoming anatomic differences and disadvantages of native porcine anatomy in which the pancreatic and common bile duct enter the duodenum in 2 separate papillae.13 Other than hemostasis and ERCP, only 1 study evaluated other interventional techniques. Training of polypectomy and dilation was investigated prospectively by comparing hands-on training and knowledge-based teaching.42 The authors demonstrated that hands-on skills training significantly improved performance in 3 therapeutic modalities, whereas knowledge-based teaching alone showed no measurable effects.42 Education and training in endoscopy is of utmost importance in health care systems all over the world. Most of the studies were performed in the United States and Europe. In Europe, the centers of training are in Germany, the UK, and France. Properly conducted outcome studies are limited, and for most major endoscopic disciplines, such as esophagogastroduodenoscopy, colonoscopy, hemostasis, and ERCP, more work is mandatory to evaluate the optimal application of each simulator for each technique. Additionally, the training concept should be reviewed. Endoscopy is a team effort of doctors and nurses with optimal patient results achieved if both work hand in hand. Our group in Erlangen performed team training courses for physicians and nurses regularly for more than 10 years, with excellent course evaluations by the trainees supporting this educational concept as effective for clinical practice.10 In Europe, endoscopy simulators are also used in another field. Animal ex vivo simulators can be used to test new devices. Our group developed a measurement system to test the efficacy of hemostatic treatment modalities. Using this experimental setup, we found that endoscopic clips are superior to injection therapy because of a longer-lasting compression effect on the surrounding tissue.21,43 The advantage of ex vivo simulators is their ability to use standard commercial equipment. Coupled with the broad availability of these models, this led to the use of endoscopy simulators to train physicians on new accessories or endoscopes, such as double-balloon enteroscopy, single-balloon enteroscopy, and endoscopic antireflux procedures (Gatekeeper, Barrx) by medical companies all over Europe.

Training activities in Europe Since the end of the 1990s with the presentation of different training models, training activities increased tremendously all over Europe. Although simulator training studies could demonstrate positive effects and improved patient outcome for some techniques, thus far obligatory simulator training has not been implemented. There is no statement published by the European societies comparable to the Principles of Training in Gastrointestinal Endoscopy, as published by the American Society for Gastrointestinal Endoscopy or statements by the Canadian Association of Gastroenterology.1,44-46 Nevertheless, all over Europe, na-

129 tional regulation exists on the number and type of endoscopic procedures to be performed during fellowship before graduation. Additionally, many European endoscopy centers and specialists enroll in training programs on their own. Some national societies have established regular course programs for interested physicians. In Germany, the working groups of Tubingen (EndoAcademy), Munich (GATE e.V.), Erlangen (EASIE and ECE), and Berlin (GATE) are active in performing regular training courses on different topics from basic upper and lower GI endoscopy to sophisticated interventional techniques such as ESD or interventional double-balloon enteroscopy. In addition, hands-on training courses on various endoscopic topics were offered during the great national meetings of the German Society of Internal Medicine or the German Society of Endoscopy and Imaging Techniques. To some extent, endoscopic experts provide industry-sponsored courses at their home hospitals. At the moment, around 50-80 courses of this kind are offered each year in Germany. In 2002, a course using ex vivo simulators for interventional endoscopy was established by the French Society of Digestive Endoscopy and is offered twice a year for gastroenterologists and gastroenterology fellows in France. This course was a result of the positive results of the National French Training Project on Endoscopic Hemostasis.39 Similar to Germany, industry-sponsored courses exist and were supplemented by regular training activities of university centers. In Austria, 4 to 5 endoscopy training courses on endoscopic hemostasis, ERCP, polypectomy, endoscopic mucosal resection, and ESD are organized annually by the Austrian Society for Gastroenterology and Hepatology. In addition, industry-sponsored training courses are offered, as in most other European countries. In Italy, some centers in Rome, Milan, Bologna, and Naples are active in providing endoscopy training. These centers perform regular training courses on different topics of interventional endoscopy. Scheduled training courses are also conducted in Belgium and the Netherlands. In the Prague/Czech Republic, a university center started 2 years ago with training courses. In the UK, 2 working groups in London at St Mark’s Hospital and Saint Mary’s Hospital are active in computer simulator– based training. In Scandinavian countries, endoscopic centers perform training courses that are regularly supported by manufacturers of endoscopes and accessories.

Future prospects For the future, there are different topics to be discussed: nearly all simulators have shown efficacy, many of which demonstrated validity in properly designed prospective randomized trials. Therefore, it is reasonable to integrate them into standard endoscopy training. However, it is not certain whether the simulator or the training concept surrounding

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the model is providing favorable results. In Germany, training courses and concepts have been developed by the German Society for Digestive and Metabolic Diseases. This GATE concept combines theoretics with practical hands-on courses using different simulators,47 leading to such questions as, Should endoscopic training should be certified? Who should be the trainer? Do we need a special certificate to become a trainer? What topics should be trained? Furthermore, the question exists of whether a license for training should be given to a certain institution or to a specific person as an expert endoscopist.2 An additional question is whether training centers should be created (“endoscopy schools”). National concepts could comprise intervals of intensive training in seminars accompanying standard education at the home institution. In France, we have made the first steps in this direction.

Conclusions New endoscopy simulators such as computer models or interventional simulators using organ packages like the Erlangen EASIE, EASIE-R, and Endo-Trainer have resulted in new perspectives for practical education as well as for the maintenance of practical skills in GI endoscopy. Such simulators are used in most European countries to varying extents. Routine training programs and courses are established in France, Austria, and Germany, but they are still not obligatory. Simulators are increasingly used for training of new instruments: in the future, simulators may be used for the evaluation of technical capabilities of individual endoscopists and may be part of quality management in gastroenterology. Whether they will become mandatory, like flight simulators for pilots, is not yet clear.

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