Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Arteriovenous Malformations
- Sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Enrollment
- 519
- Locations
- 4
- Primary Endpoint
- Instant residual rate of AVMs
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.
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.
Investigators
Shuo Wang
liuxingju
Beijing Tiantan Hospital
Eligibility 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.
Outcomes
Primary Outcomes
Instant residual rate of AVMs
Time Frame: up to 1 week after operation
The instant post-operative residual rate of AVMs
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
3 months' residual rate of AVMs
Time Frame: the date of 3rd month after operation, ±1 week
3 months' residual rate after AVM operation
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 Outcomes
- Morbidity rate of post-operative complications(7 days after operation)
- Morbidity rate of neural functional deterioration-1 week after operation(1 week after operation)
- Morbidity rate of neural functional deterioration-12 months after operation(the 12th month after operation, ±1 week)
- Post-operative mortality rate(48 hours after operation)
- Morbidity rate of neural functional deterioration-48 hours after operation(the assessing time points is 48 hours after operation)
- Morbidity rate of neural functional deterioration-3 months after operation(the 3rd month after operation, ±1 week)
- Morbidity rate of neural functional deterioration-6 months after operation(the 6th month after operation, ±1 week)