Department of Surgery, Atrium Medical Centre Parkstad, Heerlen, The Netherlands.
Ann Surg. 2010 Feb;251(2):236-43. doi: 10.1097/SLA.0b013e3181bdfbff.
The endoscopically placed duodenal-jejunal bypass sleeve or EndoBarrier Gastrointestinal Liner has been designed to achieve weight loss in morbidly obese patients. We report on the first European experience with this device.
A multicenter, randomized clinical trial was performed. Forty-one patients were included and 30 underwent sleeve implantation. Eleven patients served as a diet control group. All patients followed the same low-calorie diet during the study period. The purpose of the study was to determine the safety and efficacy of the device.
Twenty-six devices were successfully implanted. In 4 patients, implantation could not be achieved. Four devices were explanted prior to the initial protocol end point because of migration (1), dislocation of the anchor (1), sleeve obstruction (1), and continuous epigastric pain (1). The remaining patients all completed the study. Mean procedure time was 35 minutes (range: 12-102 minutes) for a successful implantation and 17 minutes (range: 5-99 minutes) for explantation. There were no procedure related adverse events. During the study period the 26 duodenal-jejunal bypass sleeve patients (100%) had at least one adverse event, mainly abdominal pain and nausea during the first week after implantation. Initial mean body mass index (BMI, kg/m2) was 48.9 and 47.4 kg/m2 for the device and control patients, respectively. Mean excess weight loss after 3 months was 19.0% for device patients versus 6.9% for control patients (P < 0.002). Absolute change in BMI at 3 months was 5.5 and 1.9 kg/m2, respectively. Type 2 diabetes mellitus was present at baseline in 8 patients of the device group and improved in 7 patients during the study period (lower glucose levels, HbA1c, and medication requirements).
The EndoBarrier Gastrointestinal Liner is a feasible and safe noninvasive device with excellent short-term weight loss results. The device also has a significant positive effect on type 2 diabetes mellitus. Long-term randomized and sham studies for weight loss and treatment of diabetes are necessary to determine the role of the device in the treatment of morbid obesity.This study was registered at www.clinicaltrials.gov (registration number: NCT00830440).
内镜下放置的十二指肠空肠旁路袖套或 EndoBarrier 胃肠道衬里旨在实现病态肥胖患者的体重减轻。我们报告了该设备在欧洲的首次应用经验。
进行了一项多中心、随机临床试验。共纳入 41 例患者，其中 30 例行袖套植入术。11 例患者作为饮食对照组。所有患者在研究期间均遵循相同的低热量饮食。本研究旨在确定该设备的安全性和有效性。
26 个设备成功植入。在 4 例患者中，无法植入。4 个设备因迁移（1 例）、锚定脱位（1 例）、袖套阻塞（1 例）和持续上腹痛（1 例）在初始方案终点前被取出。其余患者均完成了研究。对于成功植入的患者，平均手术时间为 35 分钟（范围：12-102 分钟），对于取出的患者，平均手术时间为 17 分钟（范围：5-99 分钟）。无手术相关不良事件。研究期间，26 例十二指肠空肠旁路袖套患者（100%）至少发生 1 次不良事件，主要为植入后第 1 周的腹痛和恶心。初始平均体重指数（BMI，kg/m2）分别为设备组 48.9 和对照组 47.4 kg/m2。3 个月时，设备组的超重减轻平均值为 19.0%，对照组为 6.9%（P<0.002）。3 个月时 BMI 的绝对变化分别为 5.5 和 1.9 kg/m2。设备组有 8 例患者在基线时患有 2 型糖尿病，在研究期间有 7 例患者得到改善（血糖水平、HbA1c 和药物需求降低）。
EndoBarrier 胃肠道衬里是一种可行且安全的非侵入性设备，具有出色的短期减重效果。该设备对 2 型糖尿病也有显著的积极影响。为了确定该设备在治疗病态肥胖中的作用，还需要进行长期的随机和假手术研究，以评估其在减肥和治疗糖尿病方面的效果。本研究在 www.clinicaltrials.gov 注册（注册号：NCT00830440）。
