Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas

• Conditions: Spinal Cord Vascular Diseases

• Registration Number: NCT03024749
• Lead Sponsor: Hongqi Zhang, MD

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-19
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-04
• Last Update Posted: 2017-06-06
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of the spinal cord function	1 day before operation and 12 months postoperative	American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function.Indexes (ASIA score) at baseline (1 day before operation) and 12 months follow-up will be collected, then the change from preoperative to 12 months follow-up will be assessed.

Secondary Outcome Measures

Name	Time	Method
Anatomic obliteration rate	3 months post operation	the anatomic obliteration rate is determined by angiography 3 months post operation.
American Spinal Injury Association(ASIA) Score	1 week, 3 months, 6 months, 12 months post operation
Modified Aminoff & Logue's Scale (mALS)	1 week, 3 months, 6 months, 12 months post operation
Modified Denis Pain and Numbness Scale (mDPNS)	1 week, 3 months, 6 months, 12 months post operation
Incidence of perioperative complications	1 week

Trial Locations

Locations (1)

Tao Hong; 🇨🇳 Beijing, China