Division of Gastroenterology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Gastrointest Endosc. 2016 Apr;83(4):821-5. doi: 10.1016/j.gie.2015.10.023. Epub 2015 Oct 30.
A purely endoluminal method of GI bypass would be desirable for the treatment of obstruction, obesity, or metabolic syndrome. We have developed a technology based on miniature self-assembling magnets that create large-caliber anastomoses (Incisionless Anastomosis System [IAS]). The aim of this study was to evaluate procedural characteristics of IAS deployment and long-term anastomotic integrity and patency.
We performed a 3-month survival study of Yorkshire pigs (5 interventions, 3 controls). Intervention pigs underwent simultaneous enteroscopy/colonoscopy performed with the animals under intravenous sedation. The IAS magnets were deployed and coupled with reciprocal magnets under fluoroscopy. Every 3 to 6 days pigs underwent endoscopy until jejunocolonic anastomosis (dual-path bypass) creation and magnet expulsion. Necropsies and histological evaluation were performed. The primary endpoints were technical success; secondary endpoints of anastomosis integrity, patency, and histological characteristics were weight trends.
Under intravenous sedation, endoscopic bypass creation by using IAS magnets was successfully performed in 5 of 5 pigs (100%). Given porcine anatomy, the easiest dual-path bypass to create was between the proximal jejunum and colon. The mean procedure time was 14.7 minutes. Patent, leak-free anastomoses formed by day 4. All IAS magnets were expelled by day 12. All anastomoses were fully patent at 3 months with a mean diameter of 3.5 cm. The mean 3-month weight was 45 kg in bypass pigs and 78 kg in controls (P = .01). At necropsy, adhesions were absent. Histology showed full re-epithelialization across the anastomosis without fibrosis or inflammation.
Large-caliber, leak-free, foreign body-free endoscopic intestinal bypass by using IAS magnets can be safely and rapidly performed in the porcine by model using only intravenous sedation.
对于治疗梗阻、肥胖或代谢综合征，一种纯粹的腔内胃肠道旁路方法是理想的。我们已经开发出一种基于微型自组装磁铁的技术，该技术可以创建大口径吻合口（无切口吻合系统[IAS]）。本研究的目的是评估 IAS 部署的程序特征以及长期吻合口完整性和通畅性。
我们对约克郡猪进行了为期 3 个月的生存研究（5 次干预，3 次对照）。干预组猪在静脉镇静下同时进行内镜/结肠镜检查。IAS 磁铁在透视下部署并与对侧磁铁耦合。每 3 至 6 天，猪接受内镜检查，直到创建空肠结肠吻合术（双路径旁路）和磁铁排出。进行尸检和组织学评估。主要终点是技术成功；次要终点是吻合完整性、通畅性和组织学特征，包括体重趋势。
在静脉镇静下，5 只猪（100%）均成功地通过 IAS 磁铁进行了内镜旁路手术。考虑到猪的解剖结构，最容易创建的双路径旁路是在近端空肠和结肠之间。平均手术时间为 14.7 分钟。第 4 天形成了无渗漏的吻合口。所有 IAS 磁铁均在第 12 天排出。所有吻合口在 3 个月时完全通畅，平均直径为 3.5 厘米。旁路猪的平均 3 个月体重为 45 公斤，对照组为 78 公斤（P=0.01）。尸检时无粘连。组织学显示吻合口完全上皮化，无纤维化或炎症。
在猪模型中，仅使用静脉镇静即可安全、快速地进行使用 IAS 磁铁的大口径、无渗漏、无异物的内镜肠道旁路。
