新型可拆卸内镜吻合夹治疗胃穿孔的临床前动物实验研究(含视频)

A preclinical animal study on a novel detachable endoscopic anastomosis clip for stomach perforation(with video)

目的通过动物实验应用新型内镜吻合夹全层闭合胃部穿孔,评价新型内镜吻合夹的安全性和有效性。方法以猪为实验动物,共6头,每头动物胃部造2个10~20 mm穿孔模型,利用新型内镜吻合夹闭合穿孔,观察记录实验动物存活情况、组织愈合情况,30 d后取出全部吻合夹,一半动物安乐死取标本,另一半动物再观察30 d后安乐死取标本。结果所有吻合夹植入成功(100%),30 d内创面均愈合良好,动物均存活,吻合夹自然脱落率33.3%(4/12),余下的吻合夹均成功拆解并取出,取出30 d后创面愈合良好,动物均存活。结论新型国产吻合夹操作相对简单,在动物实验中体现了良好的安全性及有效性,具有良好的临床应用前景,值得进一步的临床研究及推广。

Objective To evaluate the safety and efficacy of a novel endoscopic anastomosis clip for the stomach perforation via an animal trial.Methods Six pigs were used as experimental animals,and two perforation models(10-20 mm in diameter)were created by an endoscopic needle-knife in the stomach of each pig.The perforations were then closed by the novel detachable endoscopic anastomosis clip.The animal survival and healing of the lesions were recorded.All the clips were taken out 30 days after operation through endoscopy.Half of the animals were immediately after clip extraction and the other half of the animals survived for another 30 days owing to observation.Results All clips were implanted successfully and all lesions healed during 30 days after the operation.All animals survived.The clip natural shedding rate was 33.3%(4/12),and the rest of clips were successfully disassembled and removed.All animals were alive 30 days after clip removal with lesions healed.Conclusion The novel anastomosis clip is safe and effective in animal experiments with easy to operate.It could be recommended for further clinical research with good clinical prospect.