Clinical trial NCT03024749: Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas
Official title: Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas: Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Vascular Diseases
Keywords: Spinal Arteriovenous Malformation
Spinal Arteriovenous Fistula
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Beijing Tsinghua Chang Gung Hospital
name: Tianjin Medical University General Hospital
name: Peking University Third Hospital
name: Chinese PLA General Hospital
name: Beijing Hospital
name: General Hospital of Chinese Armed Police Forces
name: Beijing Haidian Hospital
name: China Rehabilitation Research Center
First posted: 2017-01-19
Enrollment: 380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with spinal AVMs/AVFs

Brief summary: Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex neurosurgical lesions that are very challenging to manage. Spinal vascular malformations account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our understanding of these lesions has dramatically increased thanks to neuroimaging technology (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities including conservative observation, endovascular embolization, microsurgical resection, radiation therapy, and combined therapies have been reported. The treatment for these AVMs and AVFs depends on their location, the type of malformation, the area of the spine involved, and the condition of the patient at the time of treatment. Due to the rarity of these spinal vascular lesions, reports of their management and outcomes have been limited to small series and case reports. And the rates of obliteration and outcomes are not satisfactory, especially the spinal AVMs. Spinal vascular lesions are rare but represent a formidable challenge for the treating neurosurgeon.The purpose of this study is to establish multimodality treatment mode and evaluate the anatomical cure rate and functional preservation rate.

Detailed description: This is a multicenter, prospective, observational, registration study. There are nine centers involved in the study. The investigators set up a more detailed classification system for spinal vascular malformations. In accordance with inclusion criteria and exclusion criteria, this cohort study will include 380 samples in the study period of three years. According to the spinal angiography, the correct diagnosis and treatment strategy will be made. The minimally invasive surgical treatment methods and new techniques will be adopted such as spinal superselective angiography, preoperative embolization, intraoperative electrophysiological monitoring, intraoperative angiography, etc. All the enrolled patients will be visited a total of four times, postoperative day 1 and postoperative day 7, followed up postoperative 3 months and 12 months. The anatomical cure rate and spinal cord function will be assessed objectively. All data will be recorded in the network database platform.

Eligibility criteria: Inclusion Criteria:

* patient diagnosed with spinal vascular diseases including

  * intradural arteriovenous malformation,
  * intradural arteriovenous fistula,
  * dural arteriovenous fistula,
  * extradural arteriovenous malformation,
  * paravertebral arteriovenous malformation,
  * paravertebral arteriovenous fistula,
  * cobbs' syndrome,
  * other spinal arteriovenous metameric syndromes involve the spinal cord.
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of the spinal cord function
timeFrame: 1 day before operation and 12 months postoperative
Secondary outcomes:
measure: Anatomic obliteration rate
timeFrame: 3 months post operation
measure: American Spinal Injury Association(ASIA) Score
timeFrame: 1 week, 3 months, 6 months, 12 months post operation
measure: Modified Aminoff & Logue's Scale (mALS)
timeFrame: 1 week, 3 months, 6 months, 12 months post operation
measure: Modified Denis Pain and Numbness Scale (mDPNS)
timeFrame: 1 week, 3 months, 6 months, 12 months post operation
measure: Incidence of perioperative complications
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tao Hong
Study officials:
affiliation: Neurosurgical Department, Xuanwu Hospital, Beijing
name: Zhang Hongqi, MD
role: STUDY_DIRECTOR
References:
citation: Lee YJ, Terbrugge KG, Saliou G, Krings T. Clinical features and outcomes of spinal cord arteriovenous malformations: comparison between nidus and fistulous types. Stroke. 2014 Sep;45(9):2606-12. doi: 10.1161/STROKEAHA.114.006087. Epub 2014 Jul 15.
citation: Rangel-Castilla L, Russin JJ, Zaidi HA, Martinez-Del-Campo E, Park MS, Albuquerque FC, McDougall CG, Nakaji P, Spetzler RF. Contemporary management of spinal AVFs and AVMs: lessons learned from 110 cases. Neurosurg Focus. 2014 Sep;37(3):E14. doi: 10.3171/2014.7.FOCUS14236.
citation: Gross BA, Du R. Spinal glomus (type II) arteriovenous malformations: a pooled analysis of hemorrhage risk and results of intervention. Neurosurgery. 2013 Jan;72(1):25-32; discussion 32. doi: 10.1227/NEU.0b013e318276b5d3.
citation: Gross BA, Du R. Spinal pial (type IV) arteriovenous fistulae: a systematic pooled analysis of demographics, hemorrhage risk, and treatment results. Neurosurgery. 2013 Jul;73(1):141-51; discussion 151. doi: 10.1227/01.neu.0000429848.91707.73.