Division of Minimally Invasive Surgery, Department of Surgery, University of California, 200 West Arbor Drive, #8400, San Diego, CA 92103-8400, USA.
Surg Endosc. 2011 Sep;25(9):3028-33. doi: 10.1007/s00464-011-1665-6. Epub 2011 Apr 13.
This report describes the authors' experience with a unique endoluminal, endoscopically delivered and retrieved gastroduodenojejunal bypass sleeve, including short-term weight loss and changes in comorbidities.
A prospective, single-center trial was designed. The patients were morbidly obese individuals who met the National Institutes of Health criteria for bariatric surgery. The device used was a unique gastroduodenojejunal bypass sleeve secured at the esophagogastric junction with endoscopic and laparoscopic techniques and designed to create an endoluminal gastroduodenojejunal bypass. At completion of the trial, the device was explanted with endoscopic retrieval. The primary end points were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss and changes in comorbidities, specifically glucose control, use of antihyperglycemic medications, and changes in hemoglobin A1c levels.
From July 2008 to February 2010, 24 patients were enrolled in the trial. The gastroduodenojejunal bypass sleeve was implanted, left in situ, and then retrieved. The 7 men and 17 women in the study had a mean preoperative body mass index of 42 kg/m(2). The device was successfully delivered in 22 of the 24 patients (92%) and retrieved endoscopically from all 22 patients in whom it was implanted (100%). Two patients were excluded from the study preprocedurally. The one patient was excluded preoperatively due to noncompliance with the preoperative liquid diet. For the other excluded patient, the device was not attempted endoscopically due to significant inflammation at the gastroesophageal junction at the time of laparoscopic evaluation. Of the 22 patients who had the device implanted, 17 maintained it (77%) and completed the full 12-week trial. These patients had 39.7% excess weight loss at completion of the study. The primary reason for early explantation of the device was early postoperative dysphagia. The seven patients with preoperative diabetes mellitus all had normal blood glucose levels throughout the trial, and none required antihyperglycemic medications. All four patients with elevated hemoglobin A1c levels preoperatively showed improvement by the end of the trial.
This trial demonstrated that the endoluminal gastroduodenojejunal sleeve can achieve excellent weight loss at 12 weeks. No patient safety issues were encountered. Adverse effects were minimal and resolved at endoscopic device removal. Effective glycemic control was demonstrated through use of the device during the trial. Long-term results are needed.
本报告介绍了作者在一种独特的经内镜置入和取出的胃十二指肠空肠旁路袖套方面的经验，包括短期减重和合并症的变化。
设计了一项前瞻性、单中心试验。患者为符合减肥手术国家卫生研究院标准的病态肥胖个体。使用的装置是一种独特的胃十二指肠空肠旁路袖套，通过内镜和腹腔镜技术固定在胃食管交界处，并设计用于创建经内镜胃十二指肠旁路。在试验完成时，用内镜取出进行装置取出。主要终点是安全性和不良事件的发生率。次要结果包括多余体重减轻的百分比和合并症的变化，特别是血糖控制、抗高血糖药物的使用以及血红蛋白 A1c 水平的变化。
从 2008 年 7 月至 2010 年 2 月，24 例患者入组该试验。胃十二指肠空肠旁路袖套被植入、保留原位，然后取出。该研究中的 7 名男性和 17 名女性术前平均体重指数为 42kg/m2。24 例患者中有 22 例（92%）成功地进行了器械输送，22 例植入该器械的患者（100%）均经内镜成功取出。有 2 例患者在术前被排除研究之外。其中 1 例患者因术前液体饮食不合规而在术前被排除。对于另一位被排除的患者，由于腹腔镜评估时胃食管交界处有明显炎症，因此未尝试内镜下手术。在植入该装置的 22 例患者中，有 17 例（77%）维持该装置并完成了整个 12 周的试验。这些患者在研究结束时体重减轻了 39.7%。该装置早期取出的主要原因是术后早期出现吞咽困难。术前有糖尿病的 7 例患者在整个试验过程中血糖水平均正常，均无需使用抗高血糖药物。术前血红蛋白 A1c 水平升高的 4 例患者在试验结束时均有所改善。
本试验表明，经内镜胃十二指肠旁路袖套在 12 周时可获得极好的减重效果。未出现患者安全性问题。不良事件较少，在内镜取出器械时得到解决。通过试验期间使用该装置实现了有效的血糖控制。需要长期结果。
