Stereotactic Radiosurgery With vs. Without Prior Embolization for Brain Arteriovenous Malformations: A Propensity Score Matching Analysis.
Debin Yan, Yu Chen, Zhipeng Li...
https://pubmed.ncbi.nlm.nih.gov/34712200/Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2022-05-23
2000
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are conducting a multi-center, prospective registry study to explore the long-term outcomes of brain arteriovenous malformations AVMs in mainland China. This observational study, supported by the National Key Research and Development Program, aims to find standardized diagnosis and treatment processes by comparing patients treated with and without a multidisciplinary team approach. The study involves patients aged 1 to 80 years who have confirmed AVM diagnoses using advanced imaging techniques such as digital subtraction angiography and MRI. Participants are divided into two groups an experimental group receiving treatment planned by a multidisciplinary team and a control group treated without such a protocol. Treatments include craniotomy, embolization, and stereotactic radiosurgery based on detailed preoperative evaluations. The multidisciplinary team follows strict treatment criteria depending on whether AVMs are ruptured or unruptured, recommending surgery, embolization, radiosurgery, or conservative care accordingly. The control group includes patients treated before the multidisciplinary team was established or without comprehensive evaluation. Patients data, including baseline characteristics, imaging, surgical information, and follow-up outcomes, are collected through an electronic data capture system. Neurofunctional assessments occur at baseline, 3 months, 12 months, and 3 years post-treatment, evaluating outcomes such as the modified Rankin Scale, AVM obliteration rates, hemorrhage occurrence, and complication rates. Researchers also monitor improvements in epilepsy, headache, and neurological function over time. Follow-ups are conducted via clinical visits and telephone interviews, with imaging reviewed by experienced radiologists.
CONDITIONS
Registry of Multimodality Treatment for Brain Arteriovenous Malformation in Mainland China
C
Chen Yu, MD
C
Chen Xiaolin, MD
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Beijing Tiantan Hospital
Lead Sponsor
Beijing Neurosurgical Institute
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for diagnostic imaging and clinical data collection
Duration - Up to 20 years
Participants who undergo routine care are observed. Clinical baseline data and imaging data are collected through an electronic data capture system to facilitate ongoing input at different locations and times.
Follow-up visits at 3 to 6 months after treatment and annually thereafter through clinical visits and telephone interviews
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor
Beijing Neurosurgical Institute
Collaborating Sponsor