多中心随机对照试验评价血管内主动脉瘤修复术时预防性肠系膜下动脉栓塞对瘤囊变化的疗效：Clarify IMA 研究方案。
Multicentre randomised controlled trial to evaluate the efficacy of pre-emptive inferior mesenteric artery embolisation during endovascular aortic aneurysm repair on aneurysm sac change: protocol of Clarify IMA study.
机构信息
Radiology, Nara Medical University, Kashihara, Japan
Department of Diabetes Care Medicine and Department of Metabolic Medicine, Osaka University, Suita, Osaka, Japan.
出版信息
BMJ Open. 2020 Feb 16;10(2):e031758. doi: 10.1136/bmjopen-2019-031758.
INTRODUCTION
Type II endoleak (EL) is frequently seen after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) and is often considered responsible for aneurysm sac enlargement if it persists. In order to reduce type II EL and consequent sac enlargement, pre-emptive embolisation of the inferior mesenteric artery (IMA), which is a main source for persistent type II EL, has been introduced in many vascular centres. At present, there is a lack of robust evidence to support the efficacy of pre-emptive embolisation of IMA on reduction of persistent type II EL with subsequent sac shrinkage.
METHOD AND ANALYSIS
This multicentre, randomised controlled trial will recruit 200 patients who have fusiform AAA ≥50 mm/rapidly enlarging fusiform AAA, with patent IMA, and randomly allocate them either to a pre-emptive IMA embolisation group or non-embolisation control group in a ratio of 1:1. The primary endpoint is the difference of aneurysm sac volume change assessed by CT scans between the pre-emptive IMA embolisation group and the control group at 12 months after EVAR. The secondary endpoints are defined as change of aneurysm sac volume in both groups at 6 and 24 months, freedom from sac enlargement at 12 and 24 months after EVAR, prevalence of type II EL at 1, 6, 12 and 24 months evaluated by contrast-enhanced CT, reintervention rate, aneurysm related mortality, overall survival, perioperative morbidity, volume of contrast media used during EVAR and dosage of radiation.
ETHICS AND DISSEMINATION
The protocol has been reviewed and approved by the ethics committee of Nara Medical University (No. 2113). The findings of this study will be communicated to healthcare professionals, participants and the public through peer-reviewed publications, scientific conferences and the University Hospital Medical Information Network Clinical Trials Registry home page.
TRIAL REGISTRATION NUMBER
UMIN000035502.
简介
在腹主动脉瘤（AAA）的血管内修复（EVAR）后，常可见 II 型内漏（EL），如果持续存在，常被认为是瘤囊增大的原因。为了减少 II 型 EL 及其导致的瘤囊增大，许多血管中心引入了预先栓塞肠系膜下动脉（IMA），这是持续 II 型 EL 的主要来源。目前，缺乏强有力的证据支持预先栓塞 IMA 减少持续 II 型 EL 并随后使瘤囊缩小的疗效。
方法和分析
这项多中心、随机对照试验将招募 200 名患有梭形 AAA≥50mm/快速增大梭形 AAA、IMA 通畅的患者，并以 1:1 的比例将其随机分配到预先栓塞 IMA 组或非栓塞对照组。主要终点是在 EVAR 后 12 个月，通过 CT 扫描评估预先栓塞 IMA 组和对照组之间瘤囊体积变化的差异。次要终点定义为两组在 6 个月和 24 个月时瘤囊体积的变化、EVAR 后 12 个月和 24 个月时瘤囊增大的无进展率、EVAR 后 1 个月、6 个月、12 个月和 24 个月时通过增强 CT 评估的 II 型 EL 发生率、再干预率、动脉瘤相关死亡率、总生存率、围手术期发病率、EVAR 期间使用的造影剂体积和辐射剂量。
伦理和传播
该方案已由奈良医科大学伦理委员会审查和批准（编号 2113）。本研究的结果将通过同行评议的出版物、科学会议和大学医院医疗信息网络临床试验注册主页向医疗保健专业人员、参与者和公众传达。
试验注册号
UMIN000035502。
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