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Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

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机构: [1]Capital Med Univ, Beijing Neurosurg Inst, Dept Intervent Neuroradiol, 6 Tiantan Xili, Beijing 100050, Peoples R China; [2]Capital Med Univ, Beijing Tiantan Hosp, 6 Tiantan Xili, Beijing 100050, Peoples R China; [3]Beijing Engn Res Ctr Intervent Neuroradiol, Beijing, Peoples R China
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关键词: Brain arteriovenous malformation Clinical trial Endovascular therapy Gamma knife Safety Efficacy

摘要:
Introduction: Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. Methods: This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

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大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
第一作者:
第一作者机构: [1]Capital Med Univ, Beijing Neurosurg Inst, Dept Intervent Neuroradiol, 6 Tiantan Xili, Beijing 100050, Peoples R China; [2]Capital Med Univ, Beijing Tiantan Hosp, 6 Tiantan Xili, Beijing 100050, Peoples R China; [3]Beijing Engn Res Ctr Intervent Neuroradiol, Beijing, Peoples R China
通讯作者:
通讯机构: [1]Capital Med Univ, Beijing Neurosurg Inst, Dept Intervent Neuroradiol, 6 Tiantan Xili, Beijing 100050, Peoples R China; [2]Capital Med Univ, Beijing Tiantan Hosp, 6 Tiantan Xili, Beijing 100050, Peoples R China; [3]Beijing Engn Res Ctr Intervent Neuroradiol, Beijing, Peoples R China
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