跳至主要内容
临床试验/NCT03192800
NCT03192800招募中不适用

Clinical Outcome in Patients With Spinal Dural Arteriovenous Fistulas

Hongqi Zhang, MD1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Change of the spinal cord function

研究概览

简要总结

Spinal dural arteriovenous fistulas (SDAVFs) are the most common vascular disorder of the spine and account for approximately 70% of spinal vascular malformation.They are a rare pathology with an excepted incidence of only 5-10 new cases per million inhabitants per year. Most fistulas are found in the thoracolumbar region and > 80% of all SDAVFs are located between T6 and L2, whereas the cranio-cervical, cervical and sacral fistulas are more rare. SDAVFs have an overwhelmingly male predominance (80%), with an age presentation in the fifth or sixth dacede. It is presumed that SDAVFs are acquired diseases. A typical SDAVF is located inside the dural mater close to nerve root. It is fed by a radiculomeningeal artery and enters a radicular vein that merges in the perimedullary plexus. The presence of a shunt leads to a reversal of blood flow to the spinal cord venous system, which then induces venous hypertensive myelopathy.

详细描述

The initial symptoms of venous congestion include gait disturbances, sensory symptoms (hyperesthesia and paresthesia), and sphincter dysfunction. These neurological symptoms are unspecific, so SDAVFs often go clinically underdiagnosed or misdiagnosed. But SDAVFs typically demonstrated a characteristic imaging appearance on spinal MRI including multilevel centromedullary cord T2 hyperintensity, enlarged intradural vessels along the dorsal and ventral aspect of the cord. If an SDAVF is suspected, conventional spinal angiography is required to confirm the diagnosis and determine the location of the fistula. Flowing diagnosis, expedient treatment is required, both microsurgery and endovascular embolization are safe and can achieve complete occlusion, the progression of the neurological deficits can be stopped in most instances.

However, it is difficult to predict whose symptoms will improve and whose will stabilize or deteriorate. Due to the low incidence of the SDAVFs, nearly all studies which have been published about the clinical outcome and prognostic factors of SDAVFs are relatively limited and most of them are retrospective. In these studies, the preoperative severity of disability, age, gender, location of fistula and duration of symptoms have been analyzed as prognostic factors, therefore it remains unclear which are the most reliable predictor of clinical outcome. Moreover, the conclusions may be biased by long span of follow-up period or few clinical cases. Besides, the fitulas at the craniocervical junction often present with hemorrhage, while those below conus constitute 3 types of lesions. So the invsetigator conduct this prospective cohort study to clarify the 1-year outcome of patients with cervical and thoracolumbar SDAVFs and to determine the main prognostic factors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patient diagnosed with spinal dural arteriovenous fiatulas
  • the fiatula locate between C2 and L5
  • patient not received surgical or interventional treatment before
  • patient with normal cardiac, renal and hepatic function
  • patient capable of understanding the content of the patient information / Informed Consent Form
  • patient willing and able to participate in the registry

排除标准

  • patient received surgical treatment or interventional treatment before
  • patient is pregnant patient allergic to iodine
  • patient unable to complete follow-up
  • patient with cerebral lesions patient with other spinal lesions
  • patient with cardiac, renal or hepatic dysfunction

结局指标

主要结局

Change of the spinal cord function

时间窗: 1 day before operation and 3 months, 6 months, 12 months postoperation

Modified Aminoff \& Logue's Scale for evaluating the spinal cord function

次要结局

  • Modified Denis Pain and Numbness Scale (mDPNS)(1 day before operation and 3 months, 6 months, 12 months postoperation)

研究者

发起方
Hongqi Zhang, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hongqi Zhang, MD

Director

Xuanwu Hospital, Beijing

研究点 (1)

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