Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China
NCT ID: NCT04572568
Last Updated: 2022-05-23
Study Results
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Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2011-08-01
2033-04-01
Brief Summary
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Patient baseline data, AVM angioarchitectural features, imaging DICOM data, surgical information, and follow-up information were registered. All patients were evaluated for neurofunction at baseline, 3 months, 12 months, and 3 years after treatment. Main observation endpoints: 1. Modified Rankin Scale; 2. Obliteration rate; 3. Subsequent hemorrhage; 4. Complication rate (such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications). Secondary observation endpoint: improvement of clinical symptoms (epilepsy, headache, neurological dysfunction) at 3 months, 12 months, and 3 years after treatment.
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Detailed Description
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The study cohort of this study was AVM patients aged 1-80 years. The inclusion criteria were as follows: 1. The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI); 2.Patients with complete clinical and imaging data; 3. Patient or patient's legal representative agreed to collection of information for this study and signed informed consent. The exclusion criteria were as follows: 1. Received other treatment (surgery, embolization or SRS)before inclusion; 2. Expected survival time is less than 6 months; 3. Spinal AVMs; 4. Patients missing critical baseline and imaging data.
Patients will be divided into two groups: experimental group and control group. Experimental group: Patients who had received a multidisciplinary assessment to develop a treatment plan were included in the experimental group. The details were as follows: Ruptured AVMs: 1. AVMs not involved vital eloquent areas, or more than 5 mm away from functional fiber bundles, microsurgery or hybrid surgery can be performed; 2. Targeted embolization for hemorrhagic predictors could be considered as a monotherapy; embolization can be used as an adjunctive strategy to reduce flow or volume before microsurgery or stereotactic radiosurgery (SRS); 3. SRS for patients with a volume less than 10ml and not in the acute phase(\< 3months) of hemorrhage. Volume-stage or dose-stage can be used for giant AVMs involving important eloquent areas; 4.Conservation can be used for AVMs that are prone to severe disability due to intervention. Unruptured AVMs: Interventions are recommended if unruptured AVMs are assessed as being at high rupture risk, or have refractory epilepsy or acceptable postoperative neurological deficits, otherwise conservative treatment is recommended. The choice of intervention strategy was the same as for ruptured AVM. Control group: Patients who had not received a multidisciplinary assessment to develop a treatment plan were included in the control group. It should be noted that the multidisciplinary team for AVM was formed in June 2018, so the prospective AVM cohort from August 2011 to June 2018 and the AVM cohort after June 2018 without comprehensive evaluation of treatment regimens by the multidisciplinary team served as the control group.
An electronic data capture system (EDC) was developed and used for data collection. All the clinical baseline data and imaging data were stored through a cloud server to facilitate the input work at different locations and at different times. Follow-up was conducted at the first 3-6 months and annually after surgery by clinical visit and telephone interview. The evaluation of mRS score was conducted by neurosurgeons who have at least 5 years' experience of clinical practice and all the images were interpreted by at least 2 radiologists independently who are with at least 5 years of clinical experience in radiology center of our institute. Researchers who performed follow-up assessments were blinded to treatment modalities.
The primary outcomes were as follows: modified Rankin Scale, obliteration rate, subsequent hemorrhage, complication rate (such as morbidity rate, new-onset neurological dysfunction, and radiation-related complications) at 3 months, 12 months, and 3 years after treatment. The secondary outcomes were as follows: improvement of clinical symptoms (epilepsy, headache, neurological dysfunction) at 3 months, 12 months, and 3 years after treatment.
Through the final follow-up data, we could compare the short-term outcomes and long-term outcomes between experimental and control group. In addition, intra-group comparisons can be made among subgroups of different intervention strategies to explore the best individualized treatment strategies for different AVM patients.
Treatment criteria for craniotomy: 1. For patients with a history of rupture and bleeding: a. If the lesion is not located in the deep functional area, surgical treatment is recommended; b. If the lesion is multi-system blood supply or high blood flow, the volume is large, and with a deep blood supply, hybrid surgery (embolization + resection) can be performed; c. If the lesion is located in the deep functional area, craniotomy is not recommended. 2. For patients with unruptured hemorrhage: a. If the lesion is not located in the deep brain tissue, and is not located in an important functional area or the fiber bundle is more than 5mm away from the lesion, then surgery or combined surgery can be performed; b. If the lesion is located in the deep brain tissue, important functional areas or fiber bundles are less than 5mm away from the lesion, craniotomy is not recommended; c. If the lesion does not have the above characteristics, surgical resection alone can be performed.
Interventional embolization treatment standards: 1. Ruptured bAVM should be actively treated. If there is no need for craniotomy to clear the hematoma in the acute phase, DSA should be performed 2-6 weeks after hemorrhage, and individualized treatment plans should be developed and actively treated. 2. Unruptured bAVM, if there are bleeding-related risk factors (aneurysm or high-flow fistula), relevant risk factors should be actively treated; When stereotactic radiation is planned, when craniotomy or SRS was planned, preoperative embolization for flow reduction or volume reduction is recommended; 3. Unruptured bAVM, without the above risk factors, conservative treatment was suggested if symptoms could be well controlled.
Stereotactic radiosurgery standard treatment: 1. No history of bleeding: Patients with no indications for craniotomy and with appropriate volume for radiosurgery, and poor symptom controlled. Pre-treatment imaging assessment DSA (required) and enhanced MRI was required to clarify the structure of the malformation; 2. There is a history of bleeding: the period between bleeding time and the time of consultation is less than 3 months, it is recommended to wait head-enhanced MRI and DSA were performed after the hemorrhage was absorbed (3 months) to confirm the vascular architecture. 3.Volume-stage or dose-stage can be used for giant AVMs involving important eloquent areas.
Conservation standard treatment: 1. Ruptured AVMs: Patients prone to severe disability due to intervention; 2. Unruptured AVMs: Patients were assessed as having a low rupture risk, or without refractory epilepsy or with a high risk of postoperative neurological deficits.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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experimental group
Ruptured AVMs:
1. AVMs not involved vital eloquent areas, or more than 5 mm away from functional fiber bundles, microsurgery or hybrid surgery can be performed;
2. Targeted embolization for hemorrhagic predictors could be considered as a monotherapy; embolization can be used as an adjunctive strategy to reduce flow or volume before microsurgery or stereotactic radiosurgery (SRS).
3. SRS for patients with a volume less than 10ml and not in the acute phase(\< 3months) of hemorrhage. Volume-stage or dose-stage can be used for giant AVMs involving important eloquent areas.
4. Conservation can be used for AVMs that are prone to severe disability due to intervention.
Unruptured AVMs:
Interventions are recommended if unruptured AVMs are assessed as being at high rupture risk, or have refractory epilepsy or acceptable postoperative neurological deficits, otherwise conservative treatment is recommended. The choice of intervention strategy was the same as for ruptured AVM.
Multi-disciplinary assessment
1. Comprehensive evaluation by multidisciplinary experts;
2. Preoperative multi-modal imaging examination was applied to determine the angioarchitecture, functional fiber bundle, and hemodynamics.
control group
Patients who had not received a multidisciplinary assessment to develop a treatment plan were included in the control group. It should be noted that the multidisciplinary team for AVM was formed in June 2018, so the prospective AVM cohort from August 2011 to June 2018 and the AVM cohort after June 2018 without comprehensive evaluation of treatment regimens by the multidisciplinary team served as the control group.
No interventions assigned to this group
Interventions
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Multi-disciplinary assessment
1. Comprehensive evaluation by multidisciplinary experts;
2. Preoperative multi-modal imaging examination was applied to determine the angioarchitecture, functional fiber bundle, and hemodynamics.
Eligibility Criteria
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Inclusion Criteria
2. Patients with complete clinical and imaging data.
3. Patient or patient's legal representative agreed to collection of information for this study and signed informed consent.
Exclusion Criteria
2. Expected survival time is less than 6 months;
3. Spinal AVMs;
4. Patients missing critical baseline and imaging data.
1 Year
80 Years
ALL
No
Sponsors
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Beijing Neurosurgical Institute
OTHER
Peking University International Hospital
OTHER
West China Hospital
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Sichuan Provincial People's Hospital
OTHER
The First Hospital of Jilin University
OTHER
Shanxi Provincial People's Hospital
OTHER_GOV
The Second Hospital of Shandong University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
The General Hospital of Central Theater Command
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Tianjin Medical University Second Hospital
OTHER
The First Affiliated Hospital of Shanxi Medical University
OTHER
Shengjing Hospital
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Hainan People's Hospital
OTHER
The Second Affiliated Hospital of Kunming Medical University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Second Xiangya Hospital of Central South University
OTHER
Second Affiliated Hospital of Soochow University
OTHER
General Hospital of Ningxia Medical University
OTHER
Lanzhou University Second Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Qilu Hospital of Shandong University
OTHER
Jining Medical University
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Shandong Provincial Hospital
OTHER_GOV
The Affiliated Hospital of Xuzhou Medical University
OTHER
Henan Provincial People's Hospital
OTHER
Binzhou Medical University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Principal Investigators
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Wang Shuo, MD
Role: STUDY_CHAIR
Beijing Tiantan Hospital
Li Youxiang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Neurosurgical Institute
Liu Ali, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Neurosurgical Institute
Zhao Yuanli, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Neurosurgical Institute
Chen Xiaolin, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Neurosurgical Institute
Locations
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Capital medical university affiliated Beijing Tiantan hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Meng X, Gao D, He H, Sun S, Liu A, Jin H, Li Y. A Machine Learning Model Predicts the Outcome of SRS for Residual Arteriovenous Malformations after Partial Embolization: A Real-World Clinical Obstacle. World Neurosurg. 2022 Jul;163:e73-e82. doi: 10.1016/j.wneu.2022.03.007. Epub 2022 Mar 9.
Meng X, Gao D, Jin H, Wang K, Bao E, Liu A, Li Y, Sun S. Factors Affecting Volume Reduction Velocity for Arteriovenous Malformations After Treatment With Dose-Stage Stereotactic Radiosurgery. Front Oncol. 2021 Dec 20;11:769533. doi: 10.3389/fonc.2021.769533. eCollection 2021.
Li Z, Chen Y, Chen P, Li R, Ma L, Yan D, Zhang H, Han H, Zhao Y, Zhang Y, Meng X, Jin H, Li Y, Chen X, Zhao Y. Quantitative evaluation of hemodynamics after partial embolization of brain arteriovenous malformations. J Neurointerv Surg. 2022 Nov;14(11):1112-1117. doi: 10.1136/neurintsurg-2021-018187. Epub 2021 Dec 6.
Yan D, Chen Y, Li Z, Zhang H, Li R, Yuan K, Han H, Meng X, Jin H, Gao D, Li Y, Sun S, Liu A, Chen X, Zhao Y. Stereotactic Radiosurgery With vs. Without Prior Embolization for Brain Arteriovenous Malformations: A Propensity Score Matching Analysis. Front Neurol. 2021 Oct 12;12:752164. doi: 10.3389/fneur.2021.752164. eCollection 2021.
Meng X, He H, Liu P, Gao D, Chen Y, Sun S, Liu A, Li Y, Jin H. Radiosurgery-Based AVM Scale Is Proposed for Combined Embolization and Gamma Knife Surgery for Brain Arteriovenous Malformations. Front Neurol. 2021 Mar 30;12:647167. doi: 10.3389/fneur.2021.647167. eCollection 2021.
Chen Y, Meng X, Ma L, Zhao Y, Gu Y, Jin H, Gao D, Li Y, Sun S, Liu A, Zhao Y, Chen X, Wang S. Contemporary management of brain arteriovenous malformations in mainland China: a web-based nationwide questionnaire survey. Chin Neurosurg J. 2020 Sep 1;6:26. doi: 10.1186/s41016-020-00206-0. eCollection 2020.
Chen Y, Li R, Ma L, Meng X, Yan D, Wang H, Ye X, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Long-term outcomes of brainstem arteriovenous malformations after different management modalities: a single-centre experience. Stroke Vasc Neurol. 2021 Mar;6(1):65-73. doi: 10.1136/svn-2020-000407. Epub 2020 Sep 14.
Chen Y, Yan D, Li Z, Ma L, Zhao Y, Wang H, Ye X, Meng X, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Long-Term Outcomes of Elderly Brain Arteriovenous Malformations After Different Management Modalities: A Multicenter Retrospective Study. Front Aging Neurosci. 2021 Feb 18;13:609588. doi: 10.3389/fnagi.2021.609588. eCollection 2021.
Deng Z, Chen Y, Ma L, Li R, Wang S, Zhang D, Zhao Y, Zhao J. Long-term outcomes and prognostic predictors of 111 pediatric hemorrhagic cerebral arteriovenous malformations after microsurgical resection: a single-center experience. Neurosurg Rev. 2021 Apr;44(2):915-923. doi: 10.1007/s10143-019-01210-4. Epub 2020 Feb 20.
Chen Y, Li R, Ma L, Zhao Y, Yu T, Wang H, Ye X, Wang R, Chen X, Zhao Y. Single-Stage Combined Embolization and Resection for Spetzler-Martin Grade III/IV/V Arteriovenous Malformations: A Single-Center Experience and Literature Review. Front Neurol. 2020 Oct 29;11:570198. doi: 10.3389/fneur.2020.570198. eCollection 2020.
Yu T, Han H, Ma L, Zhao Y, Zhang Y, Li Y, Wang S, Chen Y, Chen X. Learning curve and embolisation strategy in single-stage surgery combined embolisation and microsurgery for brain arteriovenous malformations: results from a nationwide multicentre prospective registry study. Stroke Vasc Neurol. 2025 Apr 7:svn-2025-004051. doi: 10.1136/svn-2025-004051. Online ahead of print.
Han H, Gao D, Ma L, Li R, Li Z, Zhang H, Yuan K, Wang K, Zhang Y, Zhao Y, Jin W, Jin H, Meng X, Yan D, Li R, Lin F, Hao Q, Wang H, Ye X, Kang S, Pu J, Shi Z, Chao X, Lin Z, Lu J, Li Y, Zhao Y, Sun S, Chen Y, Chen X, Wang S; Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China (MATCH). Long-term outcomes of microsurgery and stereotactic radiosurgery as the first-line treatment for arteriovenous malformations: a propensity score-matched analysis using nationwide multicenter prospective registry data. Int J Surg. 2023 Dec 1;109(12):3983-3992. doi: 10.1097/JS9.0000000000000751.
Li R, Chen P, Han H, Li Z, Chen X, Chen Y, Zhao Y. Association of nidus size and rupture in brain arteriovenous malformations: Insight from angioarchitecture and hemodynamics. Neurosurg Rev. 2023 Aug 31;46(1):216. doi: 10.1007/s10143-023-02113-1.
Chen Y, Han H, Jin H, Meng X, Ma L, Li R, Li Z, Yan D, Zhang H, Yuan K, Wang K, Zhao Y, Zhang Y, Jin W, Li R, Lin F, Hao Q, Wang H, Ye X, Kang S, Gao D, Pu J, Shi Z, Chao X, Lin Z, Lu J, Li J, Sun S, Liu A, Chen X, Li Y, Zhao Y, Wang S; Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China (MATCH). Association of embolization with long-term outcomes in brain arteriovenous malformations: a propensity score-matched analysis using nationwide multicenter prospective registry data. Int J Surg. 2023 Jul 1;109(7):1900-1909. doi: 10.1097/JS9.0000000000000341.
Chen Y, Han H, Ma L, Li R, Li Z, Yan D, Zhang H, Yuan K, Wang K, Zhao Y, Zhang Y, Jin W, Li R, Lin F, Meng X, Hao Q, Wang H, Ye X, Kang S, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Multimodality treatment for brain arteriovenous malformation in Mainland China: design, rationale, and baseline patient characteristics of a nationwide multicenter prospective registry. Chin Neurosurg J. 2022 Oct 17;8(1):33. doi: 10.1186/s41016-022-00296-y.
Li N, Yan D, Li Z, Chen Y, Ma L, Li R, Han H, Meng X, Jin H, Zhao Y, Chen X, Wang H, Zhao Y. Long-term outcomes of Spetzler-Martin grade IV and V arteriovenous malformations: a single-center experience. Neurosurg Focus. 2022 Jul;53(1):E12. doi: 10.3171/2022.4.FOCUS21648.
Other Identifiers
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KY 2020-003-01
Identifier Type: -
Identifier Source: org_study_id
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