Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room (SMAVMHR)
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| ClinicalTrials.gov Identifier: NCT03209804 |
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Recruitment Status :
Completed
First Posted : July 6, 2017
Last Update Posted : March 13, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Intracranial Arteriovenous Malformations | Procedure: hybrid operating techniques | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 519 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room |
| Study Start Date : | June 2016 |
| Actual Primary Completion Date : | December 2019 |
| Actual Study Completion Date : | January 16, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Traditional neurosurgical techniques
Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.
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Procedure: hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
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Experimental: Hybrid operating techniques
A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously
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Procedure: hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
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- Instant residual rate of AVMs [ Time Frame: up to 1 week after operation ]The instant post-operative residual rate of AVMs
- 3 months' residual rate of AVMs [ Time Frame: the date of 3rd month after operation, ±1 week ]3 months' residual rate after AVM operation
- 6 months' residual rate of AVMs [ Time Frame: the date of the 6th month after operation, ±1 week ]6 months' residual rate after AVM operation
- 1 year's residual rate of AVMs [ Time Frame: the date of the 12th month after operation, ±1 week ]1 year's residual rate after AVM operation
- Morbidity rate of post-operative complications [ Time Frame: 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
- Post-operative mortality rate [ Time Frame: 48 hours after operation ]operation related mortality
- Morbidity rate of neural functional deterioration-48 hours after operation [ Time Frame: 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 [ Time Frame: 1 week after operation ]The score of modified Rankin Scale increases ≥2
- Morbidity rate of neural functional deterioration-3 months after operation [ Time Frame: the 3rd month after operation, ±1 week ]The score of modified Rankin Scale increases ≥2
- Morbidity rate of neural functional deterioration-6 months after operation [ Time Frame: the 6th month after operation, ±1 week ]The score of modified Rankin Scale increases ≥2
- Morbidity rate of neural functional deterioration-12 months after operation [ Time Frame: the 12th month after operation, ±1 week ]The score of modified Rankin Scale increases ≥2
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209804
| China, Beijing | |
| Beijing Tiantan Hospital Capital Medical University | |
| Beijing, Beijing, China, 0086 | |
| General Hospital of PLA | |
| Beijing, Beijing, China, 100039 | |
| Rocket Army General Hospital of PLA | |
| Beijing, Beijing, China, 100088 | |
| Beijing Hospital | |
| Beijing, Beijing, China, 100730 | |
| Responsible Party: | Shuo Wang, liuxingju, Beijing Tiantan Hospital |
| ClinicalTrials.gov Identifier: | NCT03209804 |
| Other Study ID Numbers: |
BJTTH-002 |
| First Posted: | July 6, 2017 Key Record Dates |
| Last Update Posted: | March 13, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Intracranial Arteriovenous Malformations |
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Hemangioma Intracranial Arteriovenous Malformations Arteriovenous Malformations Congenital Abnormalities Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases Neoplasms, Vascular Tissue |
Neoplasms by Histologic Type Neoplasms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Vascular Malformations Nervous System Malformations Intracranial Arterial Diseases |