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DEVELOPMENT AND VALIDATION OF A NOVEL TISSUE-FREE SILICONE STOMACH MODEL FOR ENDOSCOPIC PROCEDURES
Leander Heisterberg
*2,1, Trent Walradt
1, Daniel Szvarca
1, Christopher C. Thompson
11Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, MA; 2ERBE Elektromedizin GmbH, Tübingen, BW, Germany
BACKGROUND: Preclinical endoscopic training is critical for skill and procedure development, but existing models have significant limitations. Porcine stomachs are anatomically different from human stomachs, being more U-shaped with a fundal diverticulum, and having thicker walls. They also require specialized animal scopes that are not usually available in endoscopy units. Commercially available plastic models lack flexibility. To address these gaps, we developed and validated a realistic, animal tissue-free silicone simulator for endoscopic training.
METHODS: A 3D gastric model was created with data generated using modeling software to replicate realistic anatomy of the distal part of the esophagus, stomach, and proximal part of the duodenum (Figure 1). The model was 3D printed, surface finished, and coated with three layers of colored silicone to replicate 1. the mucosa (soft silicone); 2. the submucosa (very soft, sticky silicone); 3. the muscularis (soft silicone). A reinforcing mesh was embedded to ensure durability. After curing, the silicone shell was separated from the 3D printed core.
The model was evaluated by a panel of ten expert endoscopists on a 4-point Likert scale based on realism (stomach shape, insufflation response, mucosal response), relevance (endoscope torque, button control, advancement/retraction), and representativeness (maneuvering through the cardia, retroflexion, and examination of the stomach). The content validity index (CVI) for realism, relevance, and representativeness was then calculated using the proportion of experts who rated the item as valid, defined as a rating of 3 (agree) or 4 (strongly agree). Face validity was assessed with yes/no responses regarding the model's potential to improve performance, its necessity for preclinical practice, and its superiority to porcine models.
RESULTS: The silicone simulator demonstrated high realism, relevance, and representativeness, achieving an overall content validity index (CVI) of 0.94 with subscores of 0.93 for realism, 1.0 for relevance, and 0.90 for representativeness. Face validity responses indicated unanimous agreement on its value for routine practice, and preclinical preparation. Seventy percent of experts thought it was superior to traditional porcine models. Proof-of-concept testing of two advanced procedures - necrosectomy through a lumen apposing metal stent and endoscopic sleeve gastroplasty with an endoscopic suturing device – were successfully completed. Full thickness stitches were achieved with the suturing device.
CONCLUSION: This novel silicone simulator provides a realistic, animal-free platform for advanced endoscopic training. Its anatomical accuracy, durability, and ability to support complex procedures provide a superior alternative to traditional porcine models and addresses key gaps in current endoscopic training methods.
Figure 1. Silicone stomach model creation and applications: A) 3D data of the stomach; B) Silicone coating consisting of three layers; C) Lumen apposing metal stent placed in the model to perform a necrosectomy; D) Grasping tissue with a forceps or E) a helix for endoscopic suturing; F) Full thickness stitches were achieved with the suturing device.
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