To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
519
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China
General Hospital of PLA
Beijing, Beijing Municipality, China
Rocket Army General Hospital of PLA
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Instant residual rate of AVMs
The instant post-operative residual rate of AVMs
Time frame: up to 1 week after operation
3 months' residual rate of AVMs
3 months' residual rate after AVM operation
Time frame: the date of 3rd month after operation, ±1 week
6 months' residual rate of AVMs
6 months' residual rate after AVM operation
Time frame: the date of the 6th month after operation, ±1 week
1 year's residual rate of AVMs
1 year's residual rate after AVM operation
Time frame: the date of the 12th month after operation, ±1 week
Morbidity rate of post-operative complications
Include intracranial hemorrhage or infarction, infection of central neural system, infection of respiratory system, cranial nerve deficits, and other symptomatic complications
Time frame: 7 days after operation
Post-operative mortality rate
operation related mortality
Time frame: 48 hours after operation
Morbidity rate of neural functional deterioration-48 hours after operation
The score of modified Rankin Scale increases ≥2
Time frame: the assessing time points is 48 hours after operation
Morbidity rate of neural functional deterioration-1 week after operation
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The score of modified Rankin Scale increases ≥2
Time frame: 1 week after operation
Morbidity rate of neural functional deterioration-3 months after operation
The score of modified Rankin Scale increases ≥2
Time frame: the 3rd month after operation, ±1 week
Morbidity rate of neural functional deterioration-6 months after operation
The score of modified Rankin Scale increases ≥2
Time frame: the 6th month after operation, ±1 week
Morbidity rate of neural functional deterioration-12 months after operation
The score of modified Rankin Scale increases ≥2
Time frame: the 12th month after operation, ±1 week