Development of a new ex vivo model for evaluation of endoscopic submucosal injection materials performance.

Abstract

Development of high-performance submucosal injection materials (SIMs) contribute to the advancement of endoscopic therapy for early-stage gastrointestinal neoplasms. This study aimed to develop a new ex vivo model that mimics the human gastrointestinal tract to evaluate the performance (the height and duration of the submucosal elevation) of various SIMs in detail. A new ex vivo model that applies a constant tension to the tested specimen (the porcine gastric specimen) was developed. SIMs were injected into the submucosa at the center or edge of the tested specimen, and submucosal elevation heights (SEHs) were measured over time. The average value and standard deviation of SEH determined using the conventional model (the tested specimen was fixed with pins) were higher than those obtained using the new model, which showed that the new model could precisely measure the SEH of a given SIM. In addition, the performance (SEH) of SIMs decreased with increasing tension applied to the specimen, suggesting that the performance of SIMs deteriorates with the over-expansion of the gastrointestinal tract. The submucosal elevation formed at the specimen edge disappeared faster than that formed at the specimen's center. The proposed new ex vivo model allows accurate SEH measurement under uniform conditions and detailed comparison of the performances of various types of SIMs and can contribute to the development of high-performance materials.