Clinical trial NCT03209804: Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Official title: Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Arteriovenous Malformations
Keywords: Intracranial Arteriovenous Malformations
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2017-07-06
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Instant residual rate of AVMs
timeFrame: up to 1 week after operation
measure: 3 months' residual rate of AVMs
timeFrame: the date of 3rd month after operation, ±1 week
measure: 6 months' residual rate of AVMs
timeFrame: the date of the 6th month after operation, ±1 week
measure: 1 year's residual rate of AVMs
timeFrame: the date of the 12th month after operation, ±1 week
Secondary outcomes:
measure: Morbidity rate of post-operative complications
timeFrame: 7 days after operation
measure: Post-operative mortality rate
timeFrame: 48 hours after operation
measure: Morbidity rate of neural functional deterioration-48 hours after operation
timeFrame: the assessing time points is 48 hours after operation
measure: Morbidity rate of neural functional deterioration-1 week after operation
timeFrame: 1 week after operation
measure: Morbidity rate of neural functional deterioration-3 months after operation
timeFrame: the 3rd month after operation, ±1 week
measure: Morbidity rate of neural functional deterioration-6 months after operation
timeFrame: the 6th month after operation, ±1 week
measure: Morbidity rate of neural functional deterioration-12 months after operation
timeFrame: the 12th month after operation, ±1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: General Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: Rocket Army General Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References: