Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room (SMAVMHR)
Primary Purpose
Intracranial Arteriovenous Malformations
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hybrid operating techniques
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Arteriovenous Malformations focused on measuring Intracranial Arteriovenous Malformations
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.
Sites / Locations
- Beijing Tiantan Hospital Capital Medical University
- General Hospital of PLA
- Rocket Army General Hospital of PLA
- Beijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Traditional neurosurgical techniques
Hybrid operating techniques
Arm Description
Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.
A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously
Outcomes
Primary Outcome Measures
Instant residual rate of AVMs
The instant post-operative residual rate of AVMs
3 months' residual rate of AVMs
3 months' residual rate after AVM operation
6 months' residual rate of AVMs
6 months' residual rate after AVM operation
1 year's residual rate of AVMs
1 year's residual rate after AVM operation
Secondary Outcome Measures
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
Post-operative mortality rate
operation related mortality
Morbidity rate of neural functional deterioration-48 hours after operation
The score of modified Rankin Scale increases ≥2
Morbidity rate of neural functional deterioration-1 week after operation
The score of modified Rankin Scale increases ≥2
Morbidity rate of neural functional deterioration-3 months after operation
The score of modified Rankin Scale increases ≥2
Morbidity rate of neural functional deterioration-6 months after operation
The score of modified Rankin Scale increases ≥2
Morbidity rate of neural functional deterioration-12 months after operation
The score of modified Rankin Scale increases ≥2
Full Information
NCT ID
NCT03209804
First Posted
June 26, 2017
Last Updated
March 12, 2020
Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Beijing Municipal Science & Technology Commission
1. Study Identification
Unique Protocol Identification Number
NCT03209804
Brief Title
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Acronym
SMAVMHR
Official Title
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
January 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Beijing Municipal Science & Technology Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arteriovenous Malformations
Keywords
Intracranial Arteriovenous Malformations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
519 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional neurosurgical techniques
Arm Type
Other
Arm Description
Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.
Arm Title
Hybrid operating techniques
Arm Type
Experimental
Arm Description
A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously
Intervention Type
Procedure
Intervention Name(s)
hybrid operating techniques
Other Intervention Name(s)
endovascular interventional embolisation, endovascular interventional balloon occlusion, microsurgical resection
Intervention Description
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Primary Outcome Measure Information:
Title
Instant residual rate of AVMs
Description
The instant post-operative residual rate of AVMs
Time Frame
up to 1 week after operation
Title
3 months' residual rate of AVMs
Description
3 months' residual rate after AVM operation
Time Frame
the date of 3rd month after operation, ±1 week
Title
6 months' residual rate of AVMs
Description
6 months' residual rate after AVM operation
Time Frame
the date of the 6th month after operation, ±1 week
Title
1 year's residual rate of AVMs
Description
1 year's residual rate after AVM operation
Time Frame
the date of the 12th month after operation, ±1 week
Secondary Outcome Measure Information:
Title
Morbidity rate of post-operative complications
Description
Include intracranial hemorrhage or infarction, infection of central neural system, infection of respiratory system, cranial nerve deficits, and other symptomatic complications
Time Frame
7 days after operation
Title
Post-operative mortality rate
Description
operation related mortality
Time Frame
48 hours after operation
Title
Morbidity rate of neural functional deterioration-48 hours after operation
Description
The score of modified Rankin Scale increases ≥2
Time Frame
the assessing time points is 48 hours after operation
Title
Morbidity rate of neural functional deterioration-1 week after operation
Description
The score of modified Rankin Scale increases ≥2
Time Frame
1 week after operation
Title
Morbidity rate of neural functional deterioration-3 months after operation
Description
The score of modified Rankin Scale increases ≥2
Time Frame
the 3rd month after operation, ±1 week
Title
Morbidity rate of neural functional deterioration-6 months after operation
Description
The score of modified Rankin Scale increases ≥2
Time Frame
the 6th month after operation, ±1 week
Title
Morbidity rate of neural functional deterioration-12 months after operation
Description
The score of modified Rankin Scale increases ≥2
Time Frame
the 12th month after operation, ±1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Beijing Tiantan Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
0086
Country
China
Facility Name
General Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Rocket Army General Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
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