Gersin Keith S, Keller Jennifer E, Stefanidis Dimitrios, Simms Connie S, Abraham Delois D, Deal Stephen E, Kuwada Timothy S, Heniford B Todd
Department of General Surgery, Carolinas Medical Center, Charlotte, North Carolina, USA.
Surg Innov. 2007 Dec;14(4):275-8. doi: 10.1177/1553350607312901.
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( trade mark) (GI Dynamics(trade mark), 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.
在美国，病态肥胖影响着超过1500万人。非手术治疗使不到5%的患者实现持续体重减轻。尽管存在相关合并症，但寻求手术干预的肥胖患者不到1%。已开发出侵入性较小的手术方法，成功率各不相同。Endobarrier（商标）（GI Dynamics（商标），马萨诸塞州沃特敦）十二指肠-空肠旁路套管是一种完全通过内镜置入的装置，旨在使病态肥胖患者体重减轻。我们描述了美国首例十二指肠-空肠旁路套管在患者体内的放置情况。一项盲法、随机、前瞻性临床试验已获美国食品药品监督管理局批准，以评估一种新型减肥装置的安全性和有效性。入组的首例患者是一名36岁女性，体重指数为45.2。在获得知情同意后，在全身麻醉下通过内镜放置该装置，并使用荧光透视法确认其位置。装置放置过程无并发症。在3个月的研究期结束时，通过内镜取出该装置。患者的总体重减轻了9.09千克。本文描述了十二指肠-空肠旁路套管在北美的首次应用。该装置以完全内镜方式应用于病态肥胖患者。在我们的患者中，3个月时的总体重减轻了9.09千克。正在继续进行随访和入组，以证明患者的安全性和有效性。正在开展更多研究以阐明该装置的减肥机制及其未来临床应用。
