Department of Cancer and Surgery, Imperial College London - St Mary's Campus, London, UK
Department of Interventional Radiology, University College London Hospitals NHS Foundation Trust, London, UK.
BMJ Open. 2023 Sep 28;13(9):e072327. doi: 10.1136/bmjopen-2023-072327.
Left gastric artery embolisation (LGAE) is a well-established treatment for major upper gastrointestinal (GI) bleeding when control is not established via upper GI endoscopy and recently has shown promising results for weight loss in small single arm studies. LGAE could be a treatment option in between our current tier-3 and tier-4 services for obesity. EMBIO is a National Institute for Health Research funded trial, a multicentre double-blinded randomised controlled trial between Imperial College National Health Service Trust and University College London Hospital, comparing LGAE versus Placebo procedure. The key aims of the trial is to evaluate LGAE efficacy on weight loss, its mechanism of action, safety profile and obesity-related comorbidities.
76 participants will be recruited from the existing tier-3 database after providing informed consent. Key inclusion criteria include adults aged 18-70 with a body mass index 35-50 kg/m and appropriate anatomy of the left gastric artery and coeliac plexus on CT Angiogram. Key exclusion criteria included previous major abdominal and bariatric surgery, weight >150 kg, type 2 diabetes on any medications other than metformin and the use of weight modifying medications. Participants will undergo mechanistic visits 1 week prior to the intervention and 3, 6 and 12 months postintervention. Informed consent will be received from each participant and they will be randomised in a 1:1 ratio to left gastric artery embolisation and placebo treatment. Blinding strategies include the use of moderate doses of sedation, visual and auditory isolation. All participants will enter a tier-3 weight management programme postintervention. The primary analysis will estimate the difference between the groups in the mean per cent weight loss at 12 months.
This trial shall be conducted in full conformity with the 1964 Declaration of Helsinki and all subsequent revisions. Local research ethics approval was granted by London-Central Research Ethics Committee, (Reference 19/LO/0509) on 11 October 2019. The Medicines and Healthcare products Regulatory Agency (MHRA) issued the Letter of No Objection on 8 April 2022 (Reference CI/2022/0008/GB). The trial's development and progress are monitored by an independent trial steering committee and data monitoring and ethics committee. The researchers plan to disseminate results at conferences, in peer- reviewed journals as well as lay media and to patient organisations.
ISRCTN16158402.
左胃动脉栓塞术（LGAE）是治疗上消化道大出血的一种成熟方法，如果在上消化道内镜检查后仍无法控制出血，可以采用该方法。最近，在一些小型单臂研究中，LGAE 显示出了治疗体重减轻的良好效果。LGAE 可能是我们目前三级和四级肥胖治疗服务之间的一种治疗选择。EMBIO 是一项由英国国家健康研究所资助的试验，是帝国理工学院国民保健信托基金会和伦敦大学学院医院之间的一项多中心、双盲、随机对照试验，比较了 LGAE 与安慰剂治疗的效果。该试验的主要目的是评估 LGAE 在体重减轻方面的疗效、作用机制、安全性概况和肥胖相关合并症。
将从现有的三级数据库中招募 76 名参与者，并在获得知情同意后进行。主要纳入标准包括年龄在 18-70 岁之间、BMI 为 35-50kg/m2 且 CT 血管造影显示左胃动脉和腹腔丛解剖结构合适的成年人。主要排除标准包括既往有重大腹部和减肥手术史、体重>150kg、除二甲双胍以外的任何药物治疗 2 型糖尿病以及使用减肥药物。参与者将在干预前 1 周、干预后 3、6 和 12 个月进行机制研究访问。将从每位参与者处获得知情同意，并按照 1:1 的比例随机分为左胃动脉栓塞组和安慰剂治疗组。盲法策略包括使用中等剂量的镇静剂、视觉和听觉隔离。所有参与者在干预后将进入三级体重管理计划。主要分析将估计两组在 12 个月时的平均体重减轻百分比之间的差异。
本试验将完全符合 1964 年《赫尔辛基宣言》及其所有后续修订版的规定。伦敦中心研究伦理委员会于 2019 年 10 月 11 日（参考 19/LO/0509）批准了该试验。药品和医疗产品监管局（MHRA）于 2022 年 4 月 8 日（参考 CI/2022/0008/GB）发出了无反对意见函。试验的发展和进展由一个独立的试验指导委员会和数据监测和伦理委员会监测。研究人员计划在会议上、同行评议期刊上以及大众媒体和患者组织中传播结果。
ISRCTN85530366。
