一种新型内镜下闭合装置用于胃肠道黏膜缺损创面闭合的初步疗效评估

A Preliminary Evaluation of a Novel Endoscopic Closure Device for the Closure of Gastrointestinal Mucosal Defects

摘要:

【目的】：内镜粘膜下剥离术后通常可以通过内镜钳道金属夹（TTSC）来闭合创面；但在面对直径大于10mm的穿孔或缺损时，TTSC有无法完全闭合的风险；对于这些较大的穿孔或缺损，可改用耙状金属夹闭合系统（OTSC）来闭合；内窥镜缝合术亦可闭合较大的粘膜缺损，降低术后迟发性出血发生率。然而，这些方法存在操作难度大、使用范围局限等不足。我们的研究旨在评估一种新型闭合装置在猪存活模型中闭合胃肠道缺损的效果。【方法】：12只实验猪在胃（n = 12）和结肠（n = 12）接受了24次粘膜剥离术，缺损平均最大径为37.60±4.02mm。24处缺损闭合均运用新型闭合装置。12只实验猪分别在7天、30天、60天接受内镜检查来评估创面愈合情况及闭合装置脱落情况。【结果】12只实验猪在60天随访期限内均未出现不良事件，在7、30、60天的内窥镜随访下，创面均完全愈合，螺纹钉平均使用数量5.46±1.53个，缺损闭合时间11.63±6.74分钟，闭合装置从第7天起开始部分脱落，第7天脱落率43.66±30.87%，30天时均完全脱落。

Abstract:

【Objective】: Following endoscopic submucosal dissection (ESD), mucosal defects are routinely sealed with through-the-scope clips (TTSCs). Nevertheless, when iatrogenic perforations or mucosal defects exceed 10 mm in diameter, TTSCs frequently fail to achieve reliable full-thickness closure. Over-the-scope clip (OTSC) systems have been employed for large defects, and endoscopic suturing platforms have similarly demonstrated efficacy in closing extensive mucosal gaps while mitigating delayed post-procedural hemorrhage. However, these approaches are encumbered by high technical complexity and a restricted clinical applicability. Our study aims to evaluate,? the safety and efficacy of a novel endoscopic closure device for gastrointestinal wall defects in a validated porcine survival model.【Methods】:12 experimental pigs underwent a total of 24 mucosal resections—12 in the stomach and 12 in the colon—with a mean maximal defect diameter of 37.60 ± 4.02 mm. All 24 defects were closed using the novel closure device. Endoscopic follow-up was performed in the 12 animals at 7, 30 and 60 days to evaluate wound healing and device retention. 【Results】: During the 60-day follow-up period, none of the 12 experimental animals experienced adverse events. Endoscopic evaluation at 7, 30, and 60 days revealed complete healing of all incisions. Deployment of the novel closure device required 5.46 ± 1.53 staples per defect, and the mean incision-closure time was 11.63 ± 6.74 min. Partial detachment of the staples was first observed on day 7, with a mean detachment rate of 43.66 ± 30.87 %; all devices had been spontaneously expelled by day 30.【Conclusions】: The application of the novel closure device for closing mucosal incisions in both gastric and intestinal tissues demonstrated a high technical success rate along with a low incidence of intraoperative and postoperative adverse events; furthermore, wound healing outcomes were favorable following closure.