新型一次性软组织闭合夹系统治疗猪胃穿孔的疗效和安全性

Effectiveness and Safety of A Novel Disposable Soft Tissue Closure Clip System in Treating Gastric Perforation in Porcine Model

目的在猪胃穿孔模型使用不同型号的新型一次性软组织闭合夹系统,行内镜下闭合,评价其有效性和安全性。方法采用小型猪建立10 mm的胃壁穿孔模型,对照组和实验组各6只。对照组于胃窦部建立1处穿孔模型,置入对照品闭合夹4枚;实验组于胃窦部建立2处胃穿孔模型,分别置入供试品A、B型闭合夹各1枚。记录动物术后的一般情况,术后第8、15天胃镜下观察穿孔闭合及修复情况,第36天取大体标本行病理学观察组织愈合和炎症情况。结果对照组和实验组闭合夹置入成功率均为100%,动物均存活,创面愈合良好。对照组闭合夹脱落率为83.3%(5/6),实验组A型闭合夹无脱落,B型闭合夹脱落率为16.7%(1/6)(P<0.05)。实验组创面愈合趋势更优。2组均未发生不良并发症。结论在本实验条件下,内镜下使用一次性软组织闭合夹系统可有效闭合胃穿孔,操作简易,具备良好的有效性和安全性。

Objective To evaluate and compare the effectiveness and safety of two models of a novel disposable soft tissue closure system for endoscopic closure of a porcine gastric perforation model.Methods Porcine stomach wall perforations(10 mm in diameter)were established in both control and experimental groups(six animals in each),endoscopically.In the control group,one perforation model was established and four control closure clips were implanted.In the experimental group,two perforation models were established in each animal and one type A closure clip and one type B closure clip were implanted,respectively.The general condition of the animals was observed and recorded after the operation,and the perforation closure and repair were observed on day 8 and day 15 post-operation,endoscopically.On day 36,dissection and gross specimen histopathological examination were performed,and the tissue healing and inflammation situation were recorded.Results The success rates of closure clip placement were 100%in both groups,and all animals survived with good wound healing.The closure clip shedding rates in the control group and experimental group with B-type closure clip were 83.3%(5/6)and 16.7%(1/6),respectively,while no shedding was found in the experimental group with A-type closure clip(P<0.05).The experimental group showed a better trend in wound healing.No adverse complication was observed in either group.Conclusion Under the experimental conditions,the use of the novel disposable soft tissue closure system for endoscopic closure of gastric perforation was effective,easy to operate and safe.