Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

Study Overview
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Brief Summary
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To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

Detailed Description
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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.

Official Title
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Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

Conditions
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Intracranial Arteriovenous Malformations

Intervention / Treatment
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* Procedure: hybrid operating techniques


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Traditional neurosurgical techniques<br>Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines. | Procedure: hybrid operating techniques<br>* A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.<br>* Other names: microsurgical resection;|
| Experimental: Hybrid operating techniques<br>A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously | Procedure: hybrid operating techniques<br>* A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.<br>* Other names: microsurgical resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Arteriovenous Malformations