First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve
First human experience with endoscopically delivered and retrieved duodenal-jejunal bypass sleeve
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DOI：
10.1016/j.soard.2007.07.012
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发表时间：
2008-01-01
影响因子：
3.1
通讯作者：
Tarnoff, Michael
中科院分区：
文献类型：
--
作者：
Rodriguez-Grunert, Leonardo;Neto, Manoel Passos Galvao;Tarnoff, Michael
背景：我们报告了社区医院首次使用内窥镜十二指肠空肠旁路套管 (DJBS) 的人类经验。方法：DJBS 是一个固定在十二指肠中的 60 厘米套管，用于创建十二指肠空肠旁路。在一项 12 名患者参与的前瞻性、开放标签、单中心、为期 12 周的研究中，该装置通过内窥镜植入、留在原位并取出。该研究包括 5 名男性和 7 名女性，平均体重指数为 43 kg/m(2)。 12 名患者中，4 名患有 2 型糖尿病。主要终点是不良事件的发生率和严重程度。次要结局包括体重过度减轻的百分比和共病状态的变化。结果：所有患者均通过内窥镜递送和取出 DJBS（平均植入/外植时间分别为 26.6 和 43.3 分钟）。在 12 名患者中，10 名患者能够维持装置 12 周，2 名患者因装置放置不当而在 9 天后接受了移植。一些自限性不良事件可能或肯定与该装置有关，包括 6 次腹痛、18 次恶心和 16 次呕吐，主要发生在植入后 2 周内。取出过程中发生两次部分咽部撕裂。所有患者均出现种植部位炎症。没有与设备相关的事件被认为是严重的。使用该装置 12 周的 10 名患者的平均体重减轻百分比为 23.6%，所有患者均实现了至少 10% 的体重减轻。在整个 12 周内，所有 4 名糖尿病患者的空腹血糖水平均正常，未服用降糖药物。在这 4 名患者中，第 12 周时，有 3 名患者的血红蛋白 A(1C) 下降≥.5%。结论：DJBS 可以安全输送并通过内窥镜取出，并留在原位 12 周。该设备具有良好的安全性和令人鼓舞的功效。随机前瞻性试验是有必要的。 （Surg Obes Relat Dis 2008；4:55-59。）(C) 2008 年美国代谢和减肥外科学会。版权所有。
Background: We report the first human experience with an endoscopic duodenal-jejunal bypass sleeve (DJBS) in a community hospital.Methods: The DJBS is a 60-cm sleeve anchored in the duodenum to create a duodenal-jejunal bypass. In a 12-patient prospective, open-label, single-center, 12-week study, the device was endoscopically implanted, left in situ, and retrieved. The study included 5 men and 7 women, with a mean body mass index of 43 kg/m(2). Of the 12 patients, 4 had type 2 diabetes. The primary endpoints were the incidence and severity of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in co-morbid status.Results: The DJBS was endoscopically delivered and retrieved in all patients (mean implant/explant time of 26.6 and 43.3 min, respectively). Of the 12 patients, 10 were able to maintain the device for 12 weeks and 2 underwent explantation after 9 days secondary to poor device placement. Several self-limited adverse events were possibly or definitely related to the device, including 6 episodes of abdominal pain, 18 of nausea, and 16 of vomiting, mainly within 2 weeks of implantation. Two partial pharyngeal tears occurred during explantation. Implant site inflammation was encountered in all patients. No device-related event was considered severe. The average percentage of excess weight loss for the 10 patients with the device in place for 12 weeks was 23.6%, with all patients achieving at least 10% excess weight loss. All 4 diabetic patients had normal fasting plasma glucose levels without hypoglycemic medication for the entire 12 weeks. Of these 4 patients, 3 had decreased hemoglobin A(1C) of >=.5% by week 12.Conclusion: The DJBS can be safely delivered and removed endoscopically and left in situ for 12 weeks. The device had a favorable safety and encouraging efficacy profile. Randomized prospective trials are warranted. (Surg Obes Relat Dis 2008;4:55-59.) (C) 2008 American Society for Metabolic and Bariatric Surgery. All rights reserved.