An Innovative Next-generation Endoscopic Submucosal Injection Material with a 2-step Injection System (with Video)

Background And Aims: Next-generation submucosal injection materials (SIMs) with higher performance and flexibility than the current SIMs (eg, 0.4% sodium hyaluronate solution [HA]) are expected to improve the outcomes of endoscopic submucosal dissection (ESD) but are difficult to develop. We developed a next-generation SIM by devising a 2-solution-type SIM comprising 2.0% calcium chloride solution (Ca) and 0.4% sodium alginate solution (SA) and evaluated its performance.

Methods: Viscoelasticity, submucosal elevation height, and injection pressure of HA, SA, and the next-generation SIM were measured. Outcomes of ESDs on pseudo-lesions in ex vivo porcine stomach/colon models were compared.

Results: The dramatic increase in SA viscoelasticity with the addition of Ca facilitated the formation of highly viscous submucosal cushions that can be controlled by endoscopists. The submucosal elevation height of the next-generation SIM was significantly higher than that of HA or SA with the same injection pressure. The ESD procedure time using the next-generation SIM was significantly shorter than that using HA or SA (14.2 ± 6.1 vs 29.2 ± 9.1 minutes, P = .0004, or 14.2 ± 6.1 vs 29.1 ± 5.9 minutes, P <.0001). Furthermore, the total injection volume for the next-generation SIM was considerably lower than that for HA or SA (7.0 ± 0.9 vs 17.2 ± 3.4 mL, P <.0001, or 7.0 ± 0.9 vs 16.2 ± 2.9 mL, P <.0001).

Conclusions: We developed an ideal next-generation SIM that achieved high performance and high flexibility in ex vivo models. Our findings warrant further investigations in a patient population.