Rodriguez-Grunert Leonardo, Galvao Neto Manoel Passos, Alamo Munir, Ramos Almino Cardoso, Baez Percy Brante, Tarnoff Michael
Centro de Cirugía de la Obesidad, Hospital DIPRECA, Las Condes, Santiago de Chile.
Surg Obes Relat Dis. 2008 Jan-Feb;4(1):55-9. doi: 10.1016/j.soard.2007.07.012.
We report the first human experience with an endoscopic duodenal-jejunal bypass sleeve (DJBS) in a community hospital.
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.
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 > or =.5% by week 12.
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.
我们报告了在一家社区医院首例使用内镜十二指肠-空肠旁路套管（DJBS）的人体经验。
DJBS是一个60厘米长的套管，固定于十二指肠以形成十二指肠-空肠旁路。在一项针对12例患者的前瞻性、开放标签、单中心、为期12周的研究中，该装置通过内镜植入、留置原位并取出。研究纳入了5名男性和7名女性，平均体重指数为43kg/m²。12例患者中，4例患有2型糖尿病。主要终点是不良事件的发生率和严重程度。次要结局包括超重减轻的百分比和共病状态的变化。
所有患者均通过内镜成功植入并取出DJBS（平均植入/取出时间分别为26.6分钟和43.3分钟）。12例患者中，10例能够将装置留置12周，2例因装置放置不佳在9天后取出。有几例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。取出过程中发生了2例部分咽部撕裂。所有患者均出现植入部位炎症。没有与装置相关的事件被认为是严重的。10例留置装置12周的患者超重减轻的平均百分比为23.6%，所有患者超重减轻均至少达到10%。所有4例糖尿病患者在整个12周内空腹血糖水平正常，无需使用降糖药物。在这4例患者中，3例在第12周时糖化血红蛋白A1c下降≥0.5%。
DJBS可以通过内镜安全地植入和取出，并留置原位12周。该装置具有良好的安全性和令人鼓舞的疗效。有必要进行随机前瞻性试验。
