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.

中文翻译：

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具有两步注射系统的创新型下一代内窥镜粘膜下注射材料（带视频）。

背景和目标

下一代粘膜下注射材料（SIM）具有比当前SIM更高的性能和灵活性（例如0.4％的透明质酸钠溶液[HA]），可改善内镜下粘膜下剥离（ESD）的疗效，但难以开发。我们通过设计包含2.0％氯化钙溶液（Ca）和0.4％海藻酸钠溶液（SA）的2溶液型SIM卡开发了下一代SIM卡，并对其性能进行了评估。

方法

测量了HA，SA和下一代SIM的粘弹性，粘膜下高度，注射压力。比较了离体猪胃/结肠模型中假性病变的ESD结果。

结果

添加钙使SA粘弹性显着增加，这有助于内镜医师控制高粘度粘膜下垫的形成。在相同的注射压力下，下一代SIM的粘膜下高度明显高于HA或SA。使用下一代SIM的ESD程序时间明显短于使用HA或SA的ESD程序时间（14.2±6.1 vs 29.2±9.1分钟，P  = .0004，或14.2±6.1 vs 29.1±5.9分钟，P  <.0001）。此外，下一代SIM的总进样量大大低于HA或SA的总进样量（7.0±0.9 vs 17.2±3.4 mL，P  <.0001，或7.0±0.9 vs 16.2±2.9 mL，P  <.0001 ）。

结论

我们开发了理想的下一代SIM，在离体模型中实现了高性能和高灵活性。我们的发现值得对患者人群进行进一步研究。