key: cord-0774449-d0d2llwr authors: Sosa-Valencia, Leonardo; Huppertz, Jerôme; Wanert, Fanélie; Haberzetser, Francois; Swanström, Lee; Mangiavillano, Benedetto; Eisendrath, Pierre; Deprez, Pierre; Robles-Medranda, Carlos; Carrara, Silvia; Al-Haddad, Mohammad A.; Vilmann, Peter; Koch, Stephane; Larghi, Alberto; Khashab, Mouen title: Design and validation of a therapeutic EUS training program using a live animal model: Taking training to the next level date: 2022-04-23 journal: Endosc Ultrasound DOI: 10.4103/eus-d-21-00124 sha: 6838002cfd7c685bf4f0a79a890db43e92422dc6 doc_id: 774449 cord_uid: d0d2llwr BACKGROUND AND OBJECTIVES: EUS has evolved into a therapeutic modality for gastrointestinal disorders. Simulators, ex vivo models, and phantoms are the current teaching methods for therapeutic EUS (TEUS). We create and evaluate a high-fidelity simulated live animal model (HiFi SAM) for teaching endoscopists TEUS. MATERIALS AND METHODS: Designing a curriculum that uses HiFi SAM and enables trainees to perform realistic procedures with expert mentors. RESULTS: Twenty-seven trainees participated in a 3-day program with 6 h of theoretical and 14 h of hands using life HiFi SAM. Eighteen experts participated. Twenty-two (20–25) TEUS were defined for each HiFi SAM, and 616 were performed in all. Of 616/264 (43%) were evaluated with a mean of 88 per course (ranging between 80 and 95). Ninety-one percent (240/264) of the procedures were completed successfully. In 24, success was not achieved due to technical and/or model problems. Student rating of HiFi SAM was: 71% excellent rating (scale 8–10) and 95% excellent/good. The HiFi SAM procedure evaluation was (scale 1–5): fine-needle biopsy: 4.79, radiofrequency: 4.76, common bile duct and gallbladder drainage: 4.75, cystic drainages: 4.72, neurolysis: 4.55, microbiopsy: 4.50, and hepatogastric drainage: 4.04, with an overall satisfaction rate of 4.56 (91%). A short survey showed: 83% would recommend absolutely (17% most likely), 33% think that ITEC training was sufficient for their practice, and 66% would like additional training, especially more practice in specific techniques rather than more clinical case discussion. Regarding impact on their practice, 66% of the trainees started a new procedure and/or noted improvement in previous ones. CONCLUSION: HiFi SAM is a complex model; however, experts and trainees are satisfied with the training this new curriculum provided. First used as a diagnostic tool for local tumor staging and the characterization of mucosal and submucosal lesions, 30 years on EUS has evolved into a valuable therapeutic modality for gastrointestinal and nondigestive disorders, transforming many surgical procedures into minimally invasive endoscopic treatments. With the development of more specific accessories, its applications have extended to all the digestive areas and organs in the mediastinum, the abdomen, the retroperitoneum, and the pelvic space. [1] [2] [3] [4] Because cases are concentrated in tertiary referral centers, the therapeutic EUS (TEUS) learning process is difficult and costly as the physician is required to spend several weeks at the teaching hospital to gather experience, which is often only observational due to regulation policies in each country. Simulators, ex vivo models, and phantoms are the current teaching methods for TEUS training. Many short courses, sometimes conducted by endoscopic societies at international congresses, train using porcine ex vivo models. This results in limited learning of diagnostic and TEUS applications such as EUS-guided fine-needle aspiration (FNA)/fine-needle biopsy (FNB), radiofrequency, and EUS-guided cystic drainage. It is evident that such courses contribute little to get practitioners beyond the learning curve. In 2001, the American Society for Gastrointestinal Endoscopy (ASGE) advocated that the minimum number of supervised pancreatic EUS was 150 with 50 FNAs to achieve proficiency in this technique. Different guidelines for EUS qualifying training have also been proposed. Ten years later, the British Society of Gastroenterology recommended to add 100 cases to the ASGE suggestion, thereby proposing that 250 cases were necessary for good quality training when starting with EUS with: 80 endoluminal cancers, 20 gastrointestinal submucosal tumors, and 150 pancreatic biliary lesions. Currently, 75 FNAs are recommended, including 45 pancreatic carcinomas. However, the number of assisted FNA has been linked to the initial number of complications. Doubling from 100 to 200 procedures showed a decrease in complications, therefore many advocates for more mentored biopsies before starting alone. [5] [6] [7] [8] [9] [10] [11] [12] [13] Moreover, in 2006, EUS training centers showed a range of 50-1100 procedures performed by their fellows with a mean of 200; at that time, 48% had achieved the ASGE-recommended 150 examinations. In TEUS, one problem is where, when, and how does one access appropriate training? Training centers remain scarce in the United States and in each European country; most are booked in advance for fellowship programs in relation to their university teaching courses. Few centers teach with live animal models. Generally, they use a normal pig to allow endoscopists to familiarize with normal EUS features and to perform biopsies (FNA/FNB) among normal liver and pancreatic tissue and some celiac reactive lymph nodes. Some centers have created biliary dilation for certain types of drainage, with a few descriptions available in current literature. Live models are very expensive and life is precious, so every living model must be used to the maximum. Therefore, more workshops with teaching platforms for TEUS with ex vivo porcine models are being proposed for participants. However, these courses are not widespread and regular training is required. Furthermore, there are many endoscopists in the world performing endosonography and/or inter ventional endoscopy without TEUS because their training took place when EUS had just been introduced to postgraduate courses, mainly as a diagnostic tool. [11, [14] [15] [16] A live standardized simulated model for TEUS has not been established. Learning EUS depends on numbers, techniques, indications, contraindications, and adverse events. Experts recommend at least 6-24 months of hands-on experience to achieve proficiency. We report on the design and validation of a high-fidelity simulated live animal model (HiFi SAM) for teaching experienced interventional endoscopists from diagnostic EUS to TEUS during an international TEUS course (ITEC). We designed a training curriculum for TEUS that uses HiFi SAM and enables trainees working in paired groups per EUS working station to perform many realistic procedures during 3 days with expert mentors selected from different countries to represent worldwide approaches. [17, 18] Materials and Methods Three meters of swine intestine with long meso was harvested before the training session and were cleaned with drinking water and frozen. Twenty-four hours before preparation, the intestines were defrosted and prepared with a special author liquid recipe. They were placed on the posterior gastric wall, each 3-5 cm long and liquid filled without air to be used for endoscopic cystic drainages. During swine surgery, 40 cm of a defunctionalized distal ileum loop was raised to the greater curvature of the stomach, filled with a special author liquid recipe, and fixed to be used for endoscopic cystic drainages. Intra-abdominal reactive lymph nodes were used for fiducial placements, FNB biopsy, and radiofrequency endoscopic ablation. 0.9% 10 mL/kg/h is continuously infused through the marginal ear vein. Antibiotics and analgesics are injected before the beginning of the surgical procedures on hands-on day. Animals are monitored during the experiment for temperature, heart rate, oxygen saturation, and capnography, to adapt anesthesia and pain management. The swine was ready for the course after 2 days and was prepared in 45 min by a team of two surgeons. Preparation consisted of: Then, to simulate real clinical practice, a contrast multi-slide scan with arterial and early venous portal phase was performed and showed to the doctor trainees before starting all procedures. This image shows a 3D reconstruction performed by Visible Patient® after scan to evaluate the models: The following EUS-guided interventions were performed During all TEUS courses, participants and experts analyzed each procedure in terms of quality and educational satisfaction. Each intervention was evaluated simultaneously using a structured survey administered by a nonexpert observer. Data included demographics and procedure details as well as the value and quality ranked using a Likert scale. A global evaluation of the procedures, including realism and the use of simulation-based education, was recorded by the trainees and experts in the form of written comments. All data were registered and analyzed by two blinded surgical educators. Experts and trainees used two scales: from 1 to 5 in the course evaluation form and from 1 to 10 in procedure skills assessment form. The course consists of a half-day theorical session and two and a half days of practical sessions. First, 3 h of ex vivo training took place with four participants and two experts using EndoSim systems for lumen apposing metallic stent training as well as plastic stents with cystic drainage from the stomach of a porcine model. Next, each two participants were attributed a mentoring expert in TEUS and performed procedures over 2 days with each 7 h of hands-on training. Experts rotated in the morning and in the afternoon for different stations while participants worked at the same station without rotating for the entire day using one HiFi SAM to accomplish a maximum number of the procedures that had being assigned. The same model was used for all procedures. Procedures were performed in order of difficulty and of risk of complications for the swine. First cystogastrostomy was done through the posterior wall of the stomach using metal and plastic stents, then microbiopsy of the gallbladder and drainage were performed and thereafter, hepaticogastrostomy or hepaticoesophagostomy drainage (swine anatomy), going from simplest to the hardest. In the afternoon, FNB of gastric submucosal tumors that were created at noon was performed and also procedures from numbers 6-10 were done including more cystogastrostomy drainage. When the left kidney drainage was possible it was used to simulate an intrahepatic bile duct drainage. All materials were supplied by: Overall, 91% (240/264) of the procedures were completed successfully. In 24 procedures, success was not achieved due to technical and/or model problems. Results of the questionnaires were: general quality of HiFi SAM: 71% excellent rating (scale 8-10), 24% good (scale 7-4), and 5% poor (scale 1-3 ). The quality of the models was judged excellent or good in 95% of the assessment forms. In 12 (5%) assessment forms, the HiFi SAM was rated poor in some swine because the sausages used as targets had a high-fat content (too white to see), the collections were not well attached to the stomach wall (very loose), normal pancreatic duct was not accessible (not visible), no rendezvous due to clipped papillae was always the case, no gastrojejunal anastomosis was possible due to bowel movements (instability), left kidney drainage was not possible due to gastric movements (untargeted kidney), difficult collections due to increased echogenicity (great heterogenicity), difficult gallbladder drainage due to intrahepatic position, and finally, insufficient intrahepatic left ductal dilation was achieved. The global evaluation (trainee and expert) of the course was collected using a 7-category questionnaire with scores on a scale from 1 to 5 After the COVID-19 pandemic, we send a short survey to our trainees for follow-up. Thirty percent of them responded. Eighty-three percent recommended the course absolutely (17% most likely), 33% thought that ITEC training itself was sufficient for their practice, and 66% would like additional training, specifically more practice in specific techniques rather than more clinical case discussion. Half of the trainees are doing more than 10 TEUS procedures per month and the other half less than 10 TEUS per month in their hospitals. The course helped decrease referrals to other centers and increase patient recruitment and broaden therapeutic options and vision for patient care in 40% of the trainees. One felt much more confident with TEUS. Gallbladder drainage, radiofrequency ablation, and glue embolization were new procedures. FNB was ameliorated technically. 66% of the trainees started a new procedure and/or improved their practice of established ones. The group from the February course had no opportunity to do any cases due to COVID-19 pandemic in their countries. EUS is difficult to learn and has a steep learning curve. Author Mohamad A. Eloubeidi described the link between EUS-guided FNA of solid pancreatic masses and defined a learning curve of 300 consecutive procedures to meet qualification requirements. Learning TEUS is equally difficult, and the problem is compounded by the ever-growing list of new EUS-guided therapeutic procedures. We describe our HiFi SAM that allowed endosonographers and/or interventional endoscopists to learn TEUS procedures during a 3-day training course, with the goal of helping them to shift from mostly diagnostic EUS to more interventional practices. The HiFi SAM was used to access and drain biliary ducts (intra-and extrahepatic), gallbladder, liquid perigastric collections of different echogenicity (in vivo and ex vivo), celiac plexus neurolysis, fiducial marker placement, radiofrequency ablation of pancreatic tissue or lymph nodes, and vascular coil and glue embolization. All TEUS procedures represent the standard of care today. [12, [19] [20] [21] [22] [23] [24] [25] [26] [27] In comparison to other ex vivo models and in vivo models used for EUS teaching, [12, 26, 27] our model is complex to prepare (two interventions and medical treatment), but this allowed us to reproduce pathological conditions found in patients. Furthermore, our course had available imaging modalities such as multi-slide contrast-enhanced scanner and 2D radiology C-arm images as would be used in clinical interventions. From 616 procedures performed, 264 were evaluated for success, quality of the model, and difficulties. All of our parameters scored above 4.2 points in a scale from 1 to 5 by all experts and trainees. We demonstrated with this study that training in TEUS is possible with high-fidelity modified (simulated) swine model allowing a high number of procedures in short period of time under the tutoring of a EUS expert. Today, the availability of expert mentors is not easy due to cost and access. For TEUS training, certain doctors will go to referral centers for observational training with an expert for several months, and this is probably one of the most widespread learning methods in interventional endoscopy. Accessibility to hands-on clinical training is more and more scarce due to increasingly restrictive laws worldwide. Finally, most of the official university programs are already full and are mainly aimed at newly qualified endoscopic gastroenterologists or surgeons who have just completed their residency program. [28] [29] [30] [31] [32] The HiFi SAM was used in the context of a 3-day training curriculum called the ITEC targeted to doctors who would benefit from an international faculty's expertise and a high-fidelity hands-on experience during a 3-day program. The major drawback to this program is its cost and resource-heavy nature that may not be universally transferable. For each workstation, a minimum of 6 persons is required: one expert, two doctor trainees, a radiology technician, a specialized assistant nurse, and an endoscopist doctor to collect all the evaluation data, without counting the important participation of endoscopic companies' staff assisting with material supplies and providing advice on the use of equipment in relation to the various procedures. During the preparation of the models, issues such as improper positioning of the collections or poorly attached collections to the stomach would happen sometimes, as is seen in Figure 9 . The objective was to develop a new teaching aid for interventional endoscopy and EUS as a tool, thereby allowing experienced endosonographers and interventional endoscopists to learn on live models, to use different EUS approaches to be able to progress toward better technique, and to have the opportunity of discovering the amazing range of EUS therapeutics to date. TEUS is the result of a significant evolution of diagnostic EUS, and this type of teaching will provide a valuable resource to the next generation of future endosonographers. As illustrated in the management of pancreatic pathologies, it is highly likely that no interventional endoscopist will be able to work without mastering TEUS procedures in future. Training under conditions that directly mimic human procedures with expert mentoring is fundamental to achieving this goal. At the IHU-Strasbourg, the HiFi SAM was integrated with a training curriculum called the "EUS Therapeutic Program (ITEC)" and received a good reception over the last 2 years. We present a new training paradigm aimed at current practitioners of EUS who wish to advance their practice by introducing more complex therapeutic procedures. The course includes a variety of procedures with expert doctors and students, didactics, and a very high-definition simmulated live animal model that allows many realistic interventions to be performed. The students and the experts reported high satisfaction with the course and the model, and most importantly, the majority reported introducing new procedures into their practice or improving older ones. However, we recommend that this type of training should be limited to endoscopists experienced in endoscopic retrograde cholangiopancreatography and EUS to achieve complete training. Figure 9 . In color green, you see the extrahepatic biliary tree dilation (common bile duct = 25 mm). A collection in color yellow is located between the gallbladder (green) and the stomach (blue), see thick black arrows. In yellow, see collections at the greater curvature separated from the stomach (blue). Esophagus and duodenum in blue Learning, techniques, and complications of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline Interventional EUS (with videos) EUS-guided pancreatic duct drainage: Ready for prime time? Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline -Updated Learning curve for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic lesions in a novel ex-vivo simulation model Training to use EUS-FNA: It is time to give up the human hands-on approach? Pre-clinical training for new notes procedures: From ex-vivo models to virtual reality simulators Development and initial validation of an endoscopic part-task training box Training in natural orifice translumenal endoscopic surgery Simulation in advanced endoscopy: State of the art and the next generation EUS training in a live pig model: Does it improve echo endoscope hands-on and trainee competence? Endoscopic ultrasound-guided fine needle aspiration training: Evaluation of a new porcine lymphadenopathy model for in vivo hands-on teaching and training, and review of the literature New ex-vivo porcine model for endoscopic ultrasound-guided training in transmural puncture and drainage of pancreatic cysts and fluid collections (with videos) Learning curves for EUS by using cumulative sum analysis: Implications for American Society for Gastrointestinal Endoscopy recommendations for training Competency in EUS: Is it the curriculum, test, trainer, or trainee? Can U.S. GI fellowship programs meet American Society for Gastrointestinal Endoscopy recommendations for training in EUS? A survey of U.S. GI fellowship program directors 27 th International Congress of the European association for endoscopic surgery High fidelity live animal models for hands-on therapeutic endoscopic ultrasound New accelerated 2-day Training in Therapeutic Endoscopic Ultrasound (TEUS) with High-Fidelity Simulated Animal Models (HFSAM) and an elevated number of procedures Satisfaction Survey, Cost and Benefits EUS-guided FNA of solid pancreatic masses: A learning curve with 300 consecutive procedures Fiducial placement for stereotactic body radiation therapy under only endoscopic ultrasonography guidance in pancreatic and hepatic malignancy: Practical feasibility and safety Long-term outcomes after endoscopic ultrasound-guided ablation of pancreatic cysts Treatment of esophageal varices: A randomized controlled trial comparing endoscopic sclerotherapy and EUS-guided sclerotherapy of esophageal collateral veins Applications of endoscopic ultrasound in pancreatic cancer EUS-guided biliary drainage Endoscopic ultrasound-guided gallbladder drainage for the management of acute cholecystitis (with video) A simple phantom for learning EUS-guided FNA A teaching model for endorectal ultrasound-guided biopsy and drainage of pararectal tumors Training in EUS-guided fine needle aspiration: Safety and diagnostic yield of attending supervised, trainee-directed FNA from the onset of training Guidelines for credentialing and granting privileges for endoscopic ultrasound Reliable and valid assessment of competence in endoscopic ultrasonography and fine-needle aspiration for mediastinal staging of non-small cell lung cancer Service provision and training for endoscopic ultrasound in the UK How shall we experience EUS and EUS-FNA before the first procedure? The development of learning tools The authors thank the IHU-Strasbourg Educational, IT, Experimental Platform, and animal care veterinarian teams for collaborating during the courses. The authors also gratefully thank the nurses and doctors of the Digestive Surgery Department and Gastroenterology Department of the Nouvel Hôpital Civil of Strasbourg, France, for their support. Furthermore, the authors also acknowledge Isabelle Petty and Lesley Daloz for contributing to this manuscript by providing language editing. Finally, thanks to the experts and trainees that participate in the course but not in the authorship of this papers due to journal requirements: Jean-Baptiste Chevaux, FR, Maxime Palazzo, FR, Schalk Van der Merwe, BE, D-W. Seo KR, Laurent Palazzo FR, and Thierry Ponchon FR. This study was financially supported by the IHU-Institute of Image-Guided Surgery, Strasbourg, France.