Duodenal-jejunal bypass sleeve: A totally endoscopic device for the treatment of morbid obesity
Duodenal-jejunal bypass sleeve: A totally endoscopic device for the treatment of morbid obesity
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DOI：
10.1177/1553350607312901
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发表时间：
2007-12-01
影响因子：
1.5
通讯作者：
Heniford, B. Todd
中科院分区：
文献类型：
--
作者：
Gersin, Keith S.;Keller, Jennifer E.;Heniford, B. Todd
在美国，病态肥胖影响着超过1500万人。非手术治疗在不到5%的患者中产生持续的体重减轻。尽管存在相关的合并症，但只有不到1%的肥胖患者寻求手术干预。已经开发了侵入性较小的程序，并取得了不同的成功。Endobarrier（TM）（GI Dynamics（TM），沃特敦，MA）空肠-空肠旁路套管是一种完全通过内窥镜输送的器械，旨在减轻病态肥胖患者的体重。我们描述了第一个在美国的病人放置回肠空肠旁路套管。美国食品和药物管理局批准了一项盲法、随机、前瞻性临床试验，以评估一种用于肥胖者减肥的新型装置的安全性和有效性。入组的第一例患者是一名36岁女性，体重指数为45.2。在获得知情同意后，在全身麻醉下使用荧光镜检查进行器械的内窥镜置入，以确认定位。植入器械，无并发症。在3个月研究期结束时，通过内窥镜取出器械。患者总体重减轻9.09 kg。本文描述的是在北美首次部署回肠-空肠旁路套管。该器械以完全内窥镜方式输送给病态肥胖患者。在我们的患者中，3个月时的总体重减轻为9.09 kg。继续随访和入组正在进行中，以证明患者的安全性和疗效。正在进行其他研究，以阐明该器械的减肥机制和未来的临床应用。
Morbid obesity affects over 15 million people in the United States. Nonsurgical management produces sustained weight loss in less than 5% of patients. Despite associated comorbidities, less than 1% of obese patients seek surgical intervention. Less invasive procedures have been developed with varying success. The Endobarrier(TM) (GI Dynamics(TM), Watertown, MA) duodenal-jejunal bypass sleeve is a totally endoscopically delivered device designed to produce weight loss in the morbidly obese. We describe the first placement of a duodenal-jejunal bypass sleeve in a patient in the United States. A blinded, randomized, prospective clinical trial was approved by the Food and Drug Administration to evaluate safety and efficacy of a novel device for weight loss in the obese. The first patient enrolled was a 36-year-old woman with body mass index of 45.2. After informed consent, endoscopic placement of the device under general anesthesia was performed using fluoroscopy to confirm positioning. The device was placed without complications. At conclusion of the 3-month study period, the device was removed endoscopically. Total weight lost by the patient was 9.09 kg. Described herein is the first deployment of the duodenal-jejunal bypass sleeve in North America. The device is delivered in a totally endoscopic manner in morbidly obese patients. In our patient, total weight loss at 3 months was 9.09 kg. Continued follow-up and enrollment is ongoing to demonstrate patient safety and efficacy. Additional studies are being performed to elucidate mechanism of weight loss and future clinical applications of this device.