Abu Dayyeh Barham K, Kumar Nitin, Edmundowicz Steven A, Jonnalagadda Sreenivasa, Larsen Michael, Sullivan Shelby, Thompson Christopher C, Banerjee Subhas
Gastrointest Endosc. 2015 Sep;82(3):425-38.e5. doi: 10.1016/j.gie.2015.03.1964. Epub 2015 Jul 29.
The increasing global burden of obesity and its associated comorbidities has created an urgent need for additional treatment options to fight this pandemic. Endoscopic bariatric therapies (EBTs) provide an effective and minimally invasive treatment approach to obesity that would increase treatment options beyond surgery, medications, and lifestyle measures. This systematic review and meta-analysis were performed by the American Society for Gastrointestinal Endoscopy (ASGE) Bariatric Endoscopy Task Force comprising experts in the subject area and the ASGE Technology Committee Chair to specifically assess whether acceptable performance thresholds outlined by an ASGE Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document for clinical adoption of available EBTs have been met. After conducting a comprehensive search of several English-language databases, we performed direct meta-analyses by using random-effects models to assess whether the Orbera intragastric balloon (IGB) (Apollo Endosurgery, Austin, Tex) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics, Lexington, Mass) have met the PIVI thresholds. The meta-analyses results indicate that the Orbera IGB meets the PIVI thresholds for both primary and nonprimary bridge obesity therapy. Based on a meta-analysis of 17 studies including 1683 patients, the percentage of excess weight loss (%EWL) with the Orbera IGB at 12 months was 25.44% (95% confidence interval [CI], 21.47%-29.41%) (random model) with a mean difference in %EWL over controls of 26.9% (95% CI, 15.66%-38.24%; P ≤ .01) in 3 randomized, controlled trials. Furthermore, the pooled percentage of total body weight loss (% TBWL) after Orbera IGB implantation was 12.3% (95% CI, 7.9%–16.73%), 13.16% (95% CI, 12.37%–13.95%), and 11.27% (95% CI, 8.17%–14.36%) at 3, 6, and 12 months after implantation, respectively, thus exceeding the PIVI threshold of 5% TBWL for nonprimary (bridge) obesity therapy. With the data available, the DJBS liner does appear to meet the %EWL PIVI threshold at 12 months, resulting in 35% EWL (95% CI, 24%-46%) but does not meet the 15% EWL over control required by the PIVI. We await review of the pivotal trial data on the efficacy and safety of this device. Data are insufficient to evaluate PIVI thresholds for any other EBT at this time. Both evaluated EBTs had ≤5% incidence of serious adverse events as set by the PIVI document to indicate acceptable safety profiles. Our task force consequently recognizes the Orbera IGB for meeting the PIVI criteria for the management of obesity. As additional data from the other EBTs become available, we will update our recommendations accordingly.
全球肥胖及其相关合并症负担日益加重,迫切需要更多治疗方案来应对这一流行病。内镜减肥疗法(EBTs)为肥胖提供了一种有效且微创的治疗方法,这将增加手术、药物和生活方式措施之外的治疗选择。这项系统评价和荟萃分析由美国胃肠内镜学会(ASGE)减肥内镜特别工作组进行,该工作组由该领域专家和ASGE技术委员会主席组成,旨在具体评估ASGE保留和纳入有价值内镜创新(PIVI)文件中为临床采用现有EBTs所概述的可接受性能阈值是否已达到。在对多个英文数据库进行全面检索后,我们使用随机效应模型进行直接荟萃分析,以评估奥贝拉胃内气球(IGB)(阿波罗内镜手术公司,得克萨斯州奥斯汀)和十二指肠空肠旁路套管(DJBS)(GI动力公司,马萨诸塞州列克星敦)是否达到PIVI阈值。荟萃分析结果表明,奥贝拉IGB在原发性和非原发性桥接肥胖治疗中均达到PIVI阈值。基于对17项研究(包括1683例患者)的荟萃分析,在3项随机对照试验中,奥贝拉IGB在12个月时的超重减轻百分比(%EWL)为25.44%(95%置信区间[CI],21.47%-29.41%)(随机模型),与对照组相比,%EWL的平均差异为26.9%(95%CI,15.66%-38.24%;P≤0.01)。此外,奥贝拉IGB植入后3、6和12个月时的总体重减轻百分比(%TBWL)分别为12.3%(95%CI,7.9%-16.73%)、13.16%(95%CI,12.37%-13.95%)和11.27%(95%CI,8.17%-14.36%),从而超过了非原发性(桥接)肥胖治疗5%TBWL的PIVI阈值。根据现有数据,DJBS内衬在12个月时似乎确实达到了%EWL的PIVI阈值,导致35%的EWL(95%CI,24%-46%),但未达到PIVI要求的比对照组多15%EWL的标准。我们正在等待对该设备疗效和安全性的关键试验数据进行审查。目前数据不足以评估任何其他EBTs的PIVI阈值。如PIVI文件所设定的,两种评估的EBTs严重不良事件发生率均≤5%,表明安全性可接受。因此,我们的特别工作组认可奥贝拉IGB符合肥胖管理的PIVI标准。随着其他EBTs的更多数据可用,我们将相应更新我们的建议。