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| Name | Class |
|---|---|
| Beijing Municipal Science & Technology Commission | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional neurosurgical techniques | Other | Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines. |
|
| Hybrid operating techniques | Experimental | A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hybrid operating techniques | Procedure | A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Instant residual rate of AVMs | The instant post-operative residual rate of AVMs | up to 1 week after operation |
| 3 months' residual rate of AVMs | 3 months' residual rate after AVM operation | the date of 3rd month after operation, ±1 week |
| 6 months' residual rate of AVMs | 6 months' residual rate after AVM operation | 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 | the date of the 12th month after operation, ±1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days after operation |
| Post-operative mortality rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Capital Medical University | Beijing | Beijing Municipality | 0086 | China | ||
| General Hospital of PLA |
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| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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operation related mortality |
| 48 hours after operation |
| Morbidity rate of neural functional deterioration-48 hours after operation | The score of modified Rankin Scale increases ≥2 | the assessing time points is 48 hours after operation |
| Morbidity rate of neural functional deterioration-1 week after operation | The score of modified Rankin Scale increases ≥2 | 1 week after operation |
| Morbidity rate of neural functional deterioration-3 months after operation | The score of modified Rankin Scale increases ≥2 | 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 | 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 | the 12th month after operation, ±1 week |
| Beijing |
| Beijing Municipality |
| 100039 |
| China |
| Rocket Army General Hospital of PLA | Beijing | Beijing Municipality | 100088 | China |
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |