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Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room (SMAVMHR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209804
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Shuo Wang, Beijing Tiantan Hospital

Brief Summary:
To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

Condition or disease Intervention/treatment Phase
Intracranial Arteriovenous Malformations Procedure: hybrid operating techniques Not Applicable

Detailed Description:

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with cerebral arteriovenous malformations, coincident with inclusion and exclusion criterion and admitted in participating organizations.

Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Residual rate of AVM is considered to be the primary observing indicator, and morbidity rate of post-operative complications, post-operative mortality rate, and morbidity rate of neural functional deterioration are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 519 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Traditional therapy group:traditional management of AVMs, such as unsimultaneous endovascular interventional embolisation, radiotherapy followed by microsurgical resection, will be conducted to patients involved in this group.

Hybrid operation group: A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously to patients in this group.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Study Start Date : June 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : January 16, 2020


Arm Intervention/treatment
Traditional neurosurgical techniques
Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.
Procedure: hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
  • endovascular interventional embolisation
  • endovascular interventional balloon occlusion
  • microsurgical resection

Experimental: Hybrid operating techniques
A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously
Procedure: hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
  • endovascular interventional embolisation
  • endovascular interventional balloon occlusion
  • microsurgical resection




Primary Outcome Measures :
  1. Instant residual rate of AVMs [ Time Frame: up to 1 week after operation ]
    The instant post-operative residual rate of AVMs

  2. 3 months' residual rate of AVMs [ Time Frame: the date of 3rd month after operation, ±1 week ]
    3 months' residual rate after AVM operation

  3. 6 months' residual rate of AVMs [ Time Frame: the date of the 6th month after operation, ±1 week ]
    6 months' residual rate after AVM operation

  4. 1 year's residual rate of AVMs [ Time Frame: the date of the 12th month after operation, ±1 week ]
    1 year's residual rate after AVM operation


Secondary Outcome Measures :
  1. Morbidity rate of post-operative complications [ Time Frame: 7 days after operation ]
    Include intracranial hemorrhage or infarction, infection of central neural system, infection of respiratory system, cranial nerve deficits, and other symptomatic complications

  2. Post-operative mortality rate [ Time Frame: 48 hours after operation ]
    operation related mortality

  3. Morbidity rate of neural functional deterioration-48 hours after operation [ Time Frame: the assessing time points is 48 hours after operation ]
    The score of modified Rankin Scale increases ≥2

  4. Morbidity rate of neural functional deterioration-1 week after operation [ Time Frame: 1 week after operation ]
    The score of modified Rankin Scale increases ≥2

  5. Morbidity rate of neural functional deterioration-3 months after operation [ Time Frame: the 3rd month after operation, ±1 week ]
    The score of modified Rankin Scale increases ≥2

  6. Morbidity rate of neural functional deterioration-6 months after operation [ Time Frame: the 6th month after operation, ±1 week ]
    The score of modified Rankin Scale increases ≥2

  7. Morbidity rate of neural functional deterioration-12 months after operation [ Time Frame: the 12th month after operation, ±1 week ]
    The score of modified Rankin Scale increases ≥2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly ruptured AVM with stable hematoma, selective operation is practical;
  • with rupture history;
  • recurrent epilepsy, failed in AED management;
  • giant AVM with deterioration of neurological functions;
  • 1-4 grade AVM (Spetzler-Martin grading system) with no symptom and not located in eloquent area.

Exclusion Criteria:

  • >70 in age, with low rupture risk;
  • newly ruptured AVM with unstable hematoma, engaged in emergency operation;
  • ≥5 grade in Spetzler-Martin grading system;
  • AVM located in hypothalamus, brainstem, cerebellopontine angle;
  • cannot tolerant the operation;
  • patient or relative refuses to participate the trail.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209804


Locations
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China, Beijing
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing, China, 0086
General Hospital of PLA
Beijing, Beijing, China, 100039
Rocket Army General Hospital of PLA
Beijing, Beijing, China, 100088
Beijing Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
Beijing Municipal Science & Technology Commission
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Responsible Party: Shuo Wang, liuxingju, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03209804    
Other Study ID Numbers: BJTTH-002
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shuo Wang, Beijing Tiantan Hospital:
Intracranial Arteriovenous Malformations
Additional relevant MeSH terms:
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Hemangioma
Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases