A Newly Designed 3-Dimensional Printer-Based Gastric Hemostasis Simulator with Two Modules for Endoscopic Trainees (with Video).

Background/Aims: We used 3-dimensional (3D) printing technology to create a new hemostasis simulator for the stomach and investigated its efficacy and realism in endoscopic hemostasis training. Methods: A new stomach hemostasis simulator, with two hemostasis modules for hemoclipping and injection, was constructed using a 3D printer. Twenty-one endoscopists, including 11 first-year fellows (beginner group) and 10 faculty members (expert group), tested the performance of the simulator. We recorded and reviewed five training sessions and evaluated the simulator with questionnaires using a 7-point Likert scale. Results: The mean evaluation score of the expert group was 6.3±0.5 for the hemoclipping module and 6.0±0.6 for the injection module. The expert group strongly agreed that endoscopic handling in the simulator was realistic and reasonable for hemostasis training. The mean procedure time for hemoclipping was 72.7±7.1 seconds for the beginner group and 19.7±1.2 seconds for the expert group. The mean procedure time for injection was 92.1±9.8 seconds for the beginner group and 36.3±2 seconds for the expert group. The procedure time of beginner group became shorter with repetition and was significantly lower by the fifth trial. Conclusions: A new 3D-printed hemostasis simulator is capable of hemostasis training and can very effectively train beginners before they perform the procedure in patients with gastrointestinal bleeding.

Animal models for endoscopic training: do we really need them?

Gastrointestinal endoscopy currently includes many therapeutic methods that are technically challenging and frequently associated with a significant risk of complications. Several issues such as the limited number of clinical cases and practice in emergency situations, and technical difficulty may limit the opportunity for training, and increased exposure in more relaxed situations would be desirable. Moreover, providing the patient with the best possible standard of care is a must. Animal models are the most easily available simulators. Training in these models has been recommended for several complex techniques, among which hemostasis, endoscopic ultrasound, endoscopic retrograde cholangiopancreatography, and endoscopic submucosal dissection are reviewed here. Ex vivo models are much easier to set up and, from an ethical standpoint, they should be used for the initial step in training whenever possible before moving on to in vivo models. Although simulation with animal models has been the subject of a good number of studies, very few of them have evaluated the impact on clinical outcomes, and clearly more studies are needed. Nevertheless, available evidence does suggest that practicing on animal models has an influence on the learning curve and facilitates the acquisition of skills in the complex endoscopic techniques reviewed.

Validation of a live animal model for training in endoscopic hemostasis of upper gastrointestinal bleeding ulcers.

BACKGROUND AND STUDY AIMS: The management of upper gastrointestinal bleeding requires training of the endoscopist. We aimed to validate a live animal model of bleeding ulcers for training in endoscopic hemostasis. MATERIALS AND METHODS: Bleeding ulcers were created by repeated grasp-and-snare gastric mucosectomies in pigs rendered "bleeders" by preadministration of clopidogrel, aspirin, and unfractionated heparin. The feasibility and reproducibility of the model (proportion of bleeding ulcers, number of ulcers per animal, and time needed to produce a bleeding ulcer) were prospectively evaluated in six animals. Ten endoscopic experts assessed the similarity of this pig model to human bleeding ulcers (four-point Likert scale). The training capabilities of the model for hemostatic techniques (needle injection, bipolar electrocoagulation, and hemoclipping) were evaluated in 46 fellows (four-point Likert scale). RESULTS: A total of 53 gastric ulcers were created in 6 animals (8.8 ± 1.5 ulcers/animal). Successful active ulcer bleeding (Forrest Ib) was achieved in 96.2 % of cases. Bleeding was moderate to abundant in 79 % of cases. Ulcerations consistently reached the submucosal layer. The mean (± SD) time taken to create a bleeding ulcer was 3.8 ± 0.6 minutes. Endoscopic experts assessed the realism of the ulcers and bleeding at 3.2 ± 0.7 and 3.6 ± 0.7 respectively on a four-point Likert scale. The training significantly improved the endoscopic skills of the 46 fellows (P < 0.0001) in all hemostatic techniques. CONCLUSIONS: The live porcine model of bleeding ulcers was demonstrated to be realistic, reproducible, feasible, time efficient, and easy to perform. It was favorably assessed as an excellent model for training in endoscopic treatment of bleeding ulcers.

Training gastroenterology fellows to perform gastric polypectomy using a novel ex vivo model.

AIM: To evaluate the effect of hands-on training of gastroenterology fellows in gastric polypectomy using an ex vivo simulator. METHODS: Eight gastroenterology fellows at Mackay Memorial Hospital, Taipei were evaluated in gastric polypectomy techniques using a pig stomach with artificial polyps created by a rubber band ligation device. The performance of four second year (year-2) fellows who had undergone one year of clinical training was compared with that of four first year (year-1) fellows both before and after a 4-h workshop using the ex vivo simulator. The workshop allowed for hands-on training in the removal of multiple artificial polyps and the placement of hemoclips at the excision site. Evaluation included observation of technical skills, procedure time, and the fellows' confidence scale. RESULTS: One week after the workshop, the year-1 fellows were re-evaluated and had significantly improved mean performance scores (from 17.9 ± 1.8 to 22.5 ± 0.7), confidence scale (from 4.5 ± 1.0 to 7.8 ± 0.5) and procedure time (from 615.0 ± 57.4 s to 357.5 ± 85.0 s) compared with their baseline performance. After 4 h of training using the ex vivo simulator, the skills of the year-1 fellows were statistically similar to those of the year-2 fellows. CONCLUSION: Use of this ex vivo simulator significantly improved the endoscopic gastric polypectomy skills of gastroenterology fellows who had not had previous clinical training in gastric polypectomy.

Training on an ex vivo animal model improves endoscopic skills: a randomized, single-blind study.

BACKGROUND: Animal models are used for training of different endoscopic procedures. Whether this really improves endoscopic skills remains controversial. OBJECTIVE: To assess the effectiveness of training by using an ex vivo animal gastric model on the performance of two therapeutic procedures-hemostasis and treatment of perforation. DESIGN: A randomized, single-blind study. SETTING: An experimental endoscopy center in a university hospital. PARTICIPANTS: Thirty-one gastroenterology fellows with comparable endoscopic experience. METHODS: Participants were randomized into two groups: with (T, n = 16) and without (S, n = 15) training. All fellows continued with standard endoscopic practice. Baseline skills were assessed at enrollment. All physicians in group T underwent 2 full days of a hands-on course over a 3-month period, in addition to their standard endoscopic practice. Both groups then underwent a blinded, final evaluation. Endoscopic skills were scored from 1 (best) to 5 (poorest) by two expert, blinded tutors. Outcomes of clinical hemostatic procedures also were analyzed. MAIN OUTCOME MEASUREMENTS: Successful hemostasis and successful perforation closure. RESULTS: Thirty physicians completed the study. Hemostasis results (n = 15): The number of physicians who carried out a successful hemostasis procedure increased significantly in the group with training (27% vs 73%; P = .009) but did not change in the group without training (20% vs 20%). The mean scores of injection and clipping technique improved significantly only after training. The number of clips used decreased significantly only in the group with training; the time of clipping did not change significantly in either group. Perforation results (n = 15): The number of physicians with a successful and complete perforation closure increased nearly significantly in the group with training (40% vs 73%, P = .06) as opposed to the group without training (27% vs 47%; P = .27). The procedure time decreased significantly in the group with training only. In clinical practice, fellows in group T had a significantly higher success rate with respect to hemostatic procedures (83.2%, range 67-100 vs 63.6%, range 25-100; P = .0447). The majority of participants (93%) agreed that such courses should be compulsory in gastroenterological credentials. LIMITATIONS: A retrospective analysis of clinical outcomes. Clinical outcome data were based on self-reporting of the participants. CONCLUSION: Hands-on training by using an animal ex vivo model improves endoscopic skills in both hemostasis and perforation closure. In clinical practice, the training improves the outcome of hemostatic procedures.

The compactEASIE is a feasible training model for endoscopic novices: a prospective randomised trial.

BACKGROUND: The objective benefit of a training using the compact Erlangen Active Simulator for Interventional Endoscopy-simulator was demonstrated in two prospective educational trials (New York, France). The present study analysed whether endoscopic novices are able to reach a comparable level of endoscopic skills as in the above-described projects. METHODS: Twenty-seven endoscopic novices (medical students, first year residents) were enrolled in this prospective, randomised trial. The compact Erlangen Active Simulator for Interventional Endoscopy-simulator with an upper GI-organ package and blood perfusion system was used as a training tool. Basic evaluation of endoscopic skills was performed after a practical and theoretical course in diagnostic upper GI endoscopy followed by a stratified randomisation according to the rating in endoscopic skills into intensive (n=14) and control group (n=13). The intensive group was trained 12 times every second week over 7 months in 4 endoscopic disciplines (manual skills, injection therapy, haemoclip, band ligation) by skilled endoscopist (three trainees/simulator). Assessment was performed (single steps/overall) using an analogue scale from 1 to 10 (1=worst, 10=optimal performance) by expert tutors. The control group was not trained. Blinded final evaluation of all participants was performed in January 2003. RESULTS: We observed in all techniques applied a significant improvement of endoscopic skills and of the performance time in the intensive group compared to the control group (p<0.001). The comparison with the previous projects showed that the intensively trained novices achieved comparable levels of performance to the GI fellows in the New York and France Project (at least 80% of the median score in three out of four techniques). CONCLUSION: Endoscopic novices acquired notable skills in interventional endoscopy in the simulator by an intensive, periodical training using the compactEASIE.

The complementary Erlangen active simulator for interventional endoscopy training is superior to solely clinical education in endoscopic hemostasis--the French training project: a prospective trial.

BACKGROUND: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) using ex-vivo porcine organs was introduced in 1997. The present study should analyze whether repeated EASIE simulator training in endoscopic hemostasis led to superior performance compared with a traditionally educated group. The results were compared with a similar project in New York. METHODS: Thirty-five French GI fellows were enrolled. Baseline skills evaluation was performed in four disciplines (manual skills, injection/coagulation, clip application and variceal ligation) using the compactEASIE-simulator equipped with an upper gastrointestinal organ package for bleeding simulation. The same, translated evaluation forms (from the prior New York project) were used. Subsequently, fellows were randomized into group A (n=17, only clinical education) and group B (n=18, additional three simulator trainings). Group B was trained the next day and after 4 and 7 months by experts of the French Society of Gastrointestinal Endoscopy. Both groups performed routine and emergency endoscopies at their home hospitals during the study period. Both groups were re-evaluated blindly after 9 months. RESULTS: The learning curve for group B showed a significant improvement in all disciplines (P<0.004) whereas group A improved significantly in only two of four disciplines at blinded final evaluation (manual skills P=0.02, injection/coagulation P=0.013). The direct comparison of groups B and A at blinded final evaluation showed significantly superior ratings for group B in all disciplines (P<0.006) and significantly shorter performance times in two disciplines (P=0.016 each). The comparison with the similar 'New York project' revealed that preexisting differences in skills were adjusted by the training. CONCLUSION: Complementary trainings (three workshops in 7 months) in endoscopic hemostasis using the compactEASIE improved skills compared with a solely clinical education. The results of the 'New York project' were confirmed and benefits were independent from the medical educational system.

Simulator training in endoscopic hemostasis.

Simulation of upper gastrointestinal (GI) hemorrhage provides the opportunity to practice endoscopic hemostasis without the risk of patient harm and time limitations. Various models have been developed to simulate an acute bleeding source in the upper GI tract to evaluate the feasibility of new endoscopic devices or to practice interventional techniques in a calm and controlled environment. Increasingly available ex vivo models provide this opportunity without the ethical concerns involved with live-animal courses. Validation studies have proven acceptance of ex vivo models and improved clinical performance by repetitive training using these models.

Efficacy and costs of a one-day hands-on EASIE endoscopy simulator train-the-trainer workshop.

BACKGROUND: The efficacy of an intensive hands-on training in endoscopic hemostasis on the compactEASIE simulator has been previously demonstrated in a randomized prospective trial. In the current study, we evaluated how quickly and effectively new tutors, without simulator training experience, are able to acquire teaching skills in endoscopic hemostasis. METHODS: Five tutors with prior Erlangen Active Simulator for Interventional Endoscopy (EASIE) teaching experience instructed 7 endoscopists without prior EASIE experience on how to teach when using the model. These new tutors then independently conducted a workshop for 8 fellows in 4 hemostasis techniques. Results were compared with a historical control trained similarly by experienced tutors. Two one-day workshops in endoscopic hemostasis on the compactEASIE ex vivo endoscopy simulator were conducted in a category A hospital in New York City, New York. Skill scores at the end of training were compared with baseline skills assessments, and qualitative ratings of the new tutors were obtained from both the trainees and the experienced tutors. RESULTS: Significant improvement was achieved by the fellows in all 4 skills areas. Both the expert tutors and the trainees consistently rated the teaching skill of the new tutors highly. Fellows' skill acquisition using new tutors was of similar magnitude to that achieved in the prior EASIE trial using experienced trainers teaching the fellows. CONCLUSIONS: It is feasible to conduct an effective EASIE train-the-trainer course in one day. Tutors trained in this manner are able to provide a similar educational experience with objective improvement in trainee skill to experts who have conducted many hands-on workshops.

Objective benefit of a 1-day training course in endoscopic hemostasis using the "compactEASIE" endoscopy simulator.

BACKGROUND AND STUDY AIMS: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) was introduced in 1997 as a training model for interventional endoscopy. Objective evidence of the benefits of training with this model has not previously been published. As part of two long-term projects, the benefits of a 1-day training course with the "compactEASIE" simulator were evaluated. MATERIALS AND METHODS: Fourteen American and 18 French gastroenterology fellows were enrolled. These fellows were participants in the intensive groups performing training in endoscopic hemostasis, with a total number of 28 fellows in New York and 36 in France. Gastrointestinal endoscopy faculty members in New York and France evaluated and timed the fellows in four disciplines to establish baseline skills (manual skills; injection and coagulation; Hemoclip application; and variceal ligation) with the compactEASIE simulator. The trainees were reevaluated after an intensive 1-day course (with two or three fellows and one instructor per station), also including preparation and assistance for each procedure. The assessment (overall and parts) was done by expert tutors using an ordinal scale ranging from 1 to 10 (1 = poorest, 10 = best), recording also mistakes and performance time. The compactEASIE simulator, equipped with an upper gastrointestinal organ package and an artificial blood perfusion system, was used as the training tool. RESULTS: A highly significant improvement ( P < or = 0.001) was observed in the performance of all endoscopic techniques. A significant reduction in performance time was also observed with three of the four endoscopic techniques. Successful hemostasis was significantly improved in two out of three techniques. CONCLUSIONS: A 1-day training course on endoscopic hemostasis using the compactEASIE simulator is capable of improving the performance of hemostasis procedures. Long-term effects of repeated training sessions are currently subject of collaborative studies in New York and France.

The compact Erlangen Active Simulator for Interventional Endoscopy: a prospective comparison in structured team-training courses on "endoscopic hemostasis" for doctors and nurses to the "Endo-Trainer" model.

BACKGROUND: In 1997 Hochberger and Neumann presented the "Erlangen Biosimulation Model" (commercialized as the "Erlangen Endo-Trainer") at various national and international meetings. The new compactEASIE is a simplified version of the original "Biosimulation Model" (Endo-Trainer) and is specially designed for easy handling. CompactEASIE is reduced in its features, focusing exclusively on flexible endoscopy training. The acceptance of training in endoscopic hemostasis is accepted by workshop participants, as evaluated by a questionnaire on both models. METHODS: Eleven structured courses on endoscopic hemostasis for doctors and nurses organized by the same endoscopists from 3/1998 to 5/1999 were evaluated using one of both models. The questionnaires were filled in by 207/291 trainees (71%). The Endo-Trainer was used in 4 (n = 103) and the compactEASIE in 7 courses (n = 104). Both simulators were equipped with identical types of specially prepared pig-organ packages consisting of esophagus, stomach and duodenum, including artificial sewn-in vessels, polyps and varices. Blood perfusion was done with a roller pump connected to the sewn-in vessels and blood surrogate. All workshops were identical concerning the course structure: a 30-min theoretical introduction on ulcer bleeding was followed by 2 h of practical training in injection techniques and hemoclip application. The second part of variceal therapy consisted of a 30-min theoretical introduction prior to 2 h of practical training on sclerotherapy, band ligation and cyanoacrylate application. Finally, a questionnaire on the trainees' pre-experience and their rating of the different workshop sections was handed out to each participant. RESULTS: Previous endoscopic experience was comparable in both groups. The training in both simulators was highly accepted by the trainees (compactEASIE 95% excellent and good versus EASIE (Endo-Trainer) 97%) and did not show any significant difference (P = 0.493). Even in the assessment of the single techniques, no statistical difference was observed. Furthermore, the assessments of the closeness to reality and the endoscopic environment in both simulators were identical. CONCLUSIONS: Both simulators (Endo-Trainer, compactEASIE) are excellent educational tools for interventional endoscopy with a high level of acceptance. The easy-to-handle, "lightweight" compactEASIE is a significant, progress tool for the future.

General principles to enhance practice patterns in gastrointestinal endoscopy.

AIM: To develop general rules on how to pursue a therapeutic goal of interventional endoscopy without getting lost in abundant details. METHODS: The influences of various medical interventions on the survival of a patient with gastrointestinal haemorrhage are modelled by an influence diagram. Survival is the focal point of multiple influences affecting its overall strength. Any downstream influence can represent the focal point of other preceding upstream influences. The mathematics underlying the influence diagram are similar to those of a decision tree with some notable exceptions. Its formalism allows one to consider inhibitory and additive influences and to include in the same analysis non-commensurable qualities, such as correct diagnosis, haemostasis or survival. RESULTS: The analysis reveals five general rules. First, the large number of factors involved in successful endoscopy render the influence of each individual factor less important. Second, a single factor that exerts its influence on many subsequent factors tends to be associated with an overall greater relevance. Third, remote influences are of lesser relevance than those directly linked to the final outcome. Fourth, factors multiplied by several consecutive probabilities lose their influence. Fifth, endoscopists need to assess the relevance of individual factors with respect to the immediate goals of endoscopy, as well as the general goals of patient well-being. CONCLUSIONS: The influence model of endoscopic haemostasis reveals several general principles that can be utilized as tools in endoscopy training.