Division of Minimally Invasive Surgery, Department of Surgery, UC San Diego, San Diego, CA, USA.
Département de Chirurgie, Université Laval, Quebec, QC, Canada.
Surg Endosc. 2018 Nov;32(11):4436-4442. doi: 10.1007/s00464-018-6186-0. Epub 2018 Apr 20.
Only a small percentage of candidates for bariatric surgery ever undergo a procedure for weight loss. Devices duplicating key effects of bariatric surgeries with removable, fully trans-oral implants could extend their benefits to patients unwilling to undergo anatomy-altering abdominal surgeries.
Thirty-two obese subjects (mean BMI: 42.3) were enrolled in a prospective, multicenter, single-arm, feasibility trial of the first fully trans-oral endoscopic gastrointestinal bypass device. The device is a cuff attached to the distal esophagus by transmural anchors and connected to a 120-cm sleeve diverting undigested nutrients to the jejunum. Bodyweight, vital signs, adverse events, medications, HbA1c, fasting glucose, and lipids were collected at baseline and follow-up visits. Device status was endoscopically assessed every 6 months.
The fully trans-oral procedure was successful in all subjects without intraoperative adverse events or postoperative infections. Twenty-eight of 32 subjects (88%) remained implanted with continuing follow-up beyond their 12-month visit. At 12 months, the 32 subjects had lost an average of 44.8% of excess body weight, 17.6% of total body weight, 20.8 kg, and 7.5 BMI points. Weight loss depended on capture of ingesta by the esophageal cuff, with 18 of 32 subjects without visible gaps around their cuffs at the 6 month endoscopy having significantly greater EWL (53.6 vs. 33.4% in the remaining subjects, p < 0.002). Mean HbA1c and fasting glucose declined by 1.1% points and 29 mg/dL in type 2 diabetic subjects, 80% of whom had remission of their diabetes at 12 months.
This study demonstrates the feasibility, safety, and efficacy of a fully trans-oral gastrointestinal bypass implant. This purely endoscopic device may provide a valuable addition to the armamentarium of treatment available for the management of morbid obesity.
只有一小部分接受减重手术的候选人会进行减肥手术。可移除的、完全经口的植入物可以复制减重手术的关键效果，将其益处扩展到不愿意接受改变腹部解剖结构的手术的患者。
32 名肥胖受试者（平均 BMI：42.3）参加了一项前瞻性、多中心、单臂、可行性试验，评估了首个完全经口内镜下胃肠旁路装置。该装置是一个通过穿壁锚固定在食管远端的袖口，与 120cm 长的套管相连，将未消化的营养物质转移到空肠。在基线和随访时收集体重、生命体征、不良事件、药物、HbA1c、空腹血糖和血脂。每 6 个月通过内镜评估设备状态。
所有受试者均成功完成完全经口手术，术中无不良事件，术后无感染。32 名受试者中有 28 名（88%）在 12 个月随访后仍继续植入。12 个月时，32 名受试者平均减轻了 44.8%的超重体重、17.6%的总体重、20.8kg 和 7.5 个 BMI 点。体重减轻取决于食管袖口对摄入物的捕获，32 名受试者中有 18 名在 6 个月内镜检查时袖口周围没有可见的间隙，其 EWL 显著更高（53.6%比其余受试者的 33.4%，p<0.002）。2 型糖尿病患者的 HbA1c 和空腹血糖平均下降 1.1 个百分点和 29mg/dL，80%的患者在 12 个月时糖尿病缓解。
这项研究证明了完全经口胃肠旁路植入的可行性、安全性和有效性。这种完全内镜设备可能为治疗病态肥胖提供一种有价值的治疗手段。
