Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 519
- 试验地点
- 4
- 主要终点
- Instant residual rate of AVMs
研究概览
简要总结
To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •>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.
结局指标
主要结局
Instant residual rate of AVMs
时间窗: up to 1 week after operation
The instant post-operative residual rate of AVMs
6 months' residual rate of AVMs
时间窗: the date of the 6th month after operation, ±1 week
6 months' residual rate after AVM operation
3 months' residual rate of AVMs
时间窗: the date of 3rd month after operation, ±1 week
3 months' residual rate after AVM operation
1 year's residual rate of AVMs
时间窗: the date of the 12th month after operation, ±1 week
1 year's residual rate after AVM operation
次要结局
- 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)
研究者
Shuo Wang
liuxingju
Beijing Tiantan Hospital