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食管黏膜下隧道封闭与支架固定与不封闭以确保经口内镜下微创手术入路的前瞻性、随机临床试验。

A prospective, randomized trial of esophageal submucosal tunnel closure with a stent versus no closure to secure a transesophageal natural orifice transluminal endoscopic surgery access site.

机构信息

Gastroenterology Unit, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.

出版信息

Gastrointest Endosc. 2011 Apr;73(4):785-90. doi: 10.1016/j.gie.2010.11.025. Epub 2011 Feb 2.

DOI:10.1016/j.gie.2010.11.025
PMID:21288511
Abstract

BACKGROUND

Secure esophagotomy closure methods are a critical element in the advancement of transesophageal natural orifice transluminal endoscopic surgery (NOTES) procedures.

OBJECTIVE

To compare the clinical outcomes in swine receiving an esophageal stent or no stent after a submucosal tunnel NOTES access procedure.

DESIGN

Prospective, randomized, controlled trial in 10 Yorkshire swine.

SETTING

Academic center.

INTERVENTION

An endoscopic mucosectomy device was used to create an esophageal mucosal defect. An endoscope was advanced through a submucosal tunnel into the mediastinum and thorax, and diagnostic mediastinoscopy and thoracoscopy were performed. Ten animals were randomized to no stenting (n = 5) or stenting (n = 5) with a prototype small-intestine submucosa-covered stent.

MAIN OUTCOME MEASUREMENTS

Gross and histologic appearance of the mucosectomy and esophagotomy sites as well as clinical outcomes.

RESULTS

There was a significant difference in the overall procedure time between the animals that received a stent (35.0 min, range 27-46.0 min) and those with no closure (19.0 min, range 17-32 min) (P value = .018). The unstented group achieved endoscopic and histologic evidence of complete re-epithelialization and healing (100%) at the mucosectomy site compared with the stented group (20%, P = .048). Stent migration into the stomach occurred in two swine. Both groups had complete closure of the submucosal tunnel and well-healed esophagotomy sites.

LIMITATIONS

Animal study, small number of subjects.

CONCLUSION

The placement of a covered esophageal stent significantly interferes with mucosectomy site healing.

摘要

背景

安全的食管切开闭合方法是经食管自然腔道内镜外科(NOTES)手术发展的关键要素。

目的

比较猪接受黏膜下隧道NOTES 入路手术后接受或不接受食管支架的临床结果。

设计

前瞻性、随机、对照试验,共纳入 10 头约克夏猪。

地点

学术中心。

干预措施

使用内镜黏膜切除术装置创建食管黏膜缺损。内镜通过黏膜下隧道进入纵隔和胸腔,并进行诊断性纵隔镜检查和胸腔镜检查。10 头动物随机分为无支架组(n = 5)或支架组(n = 5),支架组使用原型小肠黏膜下覆盖支架。

主要观察指标

黏膜切除术和食管切开部位的大体和组织学表现以及临床结果。

结果

支架组(35.0 min,范围 27-46.0 min)与无闭合组(19.0 min,范围 17-32 min)的整体手术时间有显著差异(P 值 =.018)。未支架组黏膜切除术部位内镜和组织学均显示完全上皮化和愈合(100%),而支架组为 20%(P =.048)。两组均有完全闭合的黏膜下隧道和愈合良好的食管切开部位。

局限性

动物研究,样本量小。

结论

覆盖食管支架的放置显著干扰黏膜切除术部位的愈合。

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