Intracranial Arteriovenous Malformations
Conditions
Keywords
Intracranial Arteriovenous Malformations
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.
Interventions
PROCEDUREhybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Sponsors
Beijing Municipal Science & Technology Commission
Ministry of Science and Technology of the People´s Republic of China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Instant residual rate of AVMs | up to 1 week after operation | The instant post-operative residual rate of AVMs |
| 3 months' residual rate of AVMs | the date of 3rd month after operation, ±1 week | 3 months' residual rate after AVM operation |
| 6 months' residual rate of AVMs | the date of the 6th month after operation, ±1 week | 6 months' residual rate after AVM operation |
| 1 year's residual rate of AVMs | the date of the 12th month after operation, ±1 week | 1 year's residual rate after AVM operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity rate of neural functional deterioration-3 months after operation | the 3rd month after operation, ±1 week | The score of modified Rankin Scale increases ≥2 |
| Morbidity rate of post-operative complications | 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 |
| Morbidity rate of neural functional deterioration-12 months after operation | the 12th month after operation, ±1 week | The score of modified Rankin Scale increases ≥2 |
| Morbidity rate of neural functional deterioration-6 months after operation | the 6th month after operation, ±1 week | The score of modified Rankin Scale increases ≥2 |
| Post-operative mortality rate | 48 hours after operation | operation related mortality |
| Morbidity rate of neural functional deterioration-48 hours after operation | the assessing time points is 48 hours after operation | The score of modified Rankin Scale increases ≥2 |
| Morbidity rate of neural functional deterioration-1 week after operation | 1 week after operation | The score of modified Rankin Scale increases ≥2 |
Countries
China
Outcome results
None listed