This nationwide multicenter prospective cohort study will collect the treatment information and outcomes of the patients with previously untreated cavernous malformations (U-CMs) in China (at least 2000 patients from 20 centers). The investigators aim to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.
Despite the availability of microsurgical excision and stereotactic radiosurgery for cavernoma treatment and known genetic causes of most familial forms of cavernoma, uncertainties remain about cause, diagnosis, prognosis, treatment, and care. According to the recently published CM treatment guideline, surgical and conservative treatments are both first-line therapeutic options in previously untreated CMs (U-CMs). However, given current data, neurosurgeons are still unable to counsel patients on which would be the best option. To address the absence of high level evidence to support cerebral CM treatment decisions, there is a need for a large sample size study of cerebral CM treatment with a prospective concurrent group. China has the largest population in the world and may have the most extensive and valuable clinical resources of U-CMs. But, till now, the current treatment and outcome situation of the disease in China is not well known. Thus, the investigators are conducting a nationwide multicenter prospective registry study in China to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.At least 2000 patients with untreated cerebral cavernous malformation will be enrolled from 20 Grade Ⅲ A level hospitals distributed all over China. Clinical data and laboratory data are prospectively collected by electric case report form (CRF) and uploaded online by each neurosurgery center to form the prospective clinical database in First Affiliated Hospital of Fujian Medical University. This is a cohort follow-up study across a 5-year period with a 2 years interval of enrollment and 3 years follow up for each patient.
Study Type
OBSERVATIONAL
Enrollment
2,000
For patient in surgically treated group, surgical removal of intracerebral CMs by craniotomy is performed according to the principles as follows: less transgression of normal brain tissue; identification and protection of eloquent brain tissue; sparing associated developmental venous anomaly; hemosiderin rim resection for non-eloquent and superficial CMs and sparing yellowish tissue for eloquent and deep ones; Extended resections (mesial resection, standard temporal lobe resection) are recommend for epileptogenic CMs based on intra-operative EEG.
Observation is performed in conservatively treated patients with best medicine and supportive treatment, such as antiepileptic drugs, analgesic drugs and neurotrophic drugs. For patients with underlying diseases such as hypertension, hyperlipidemia or diabetes mellitus, after consulting with the relevant experts, the patients can be treated accordingly.
The first affiliated hospital of fujian medical university
Fuzhou, Fujian, China
RECRUITINGPoor outcome
The primary outcome of this study is patients with poor outcome (mRS\>2 lasting at least 1year) at the last follow up.
Time frame: 3 years
symptomatic hemorrhage
Requiring acute or subacute onset symptoms (any of headache, epileptic seizure, impaired consciousness, or new/worsened brain function deficit referable to the anatomic location of the CM) accompanied by radiological, pathological, surgical, or rarely only cerebrospinal fluid evidence of recent extra- or intralesional hemorrhage.
Time frame: 3 years
drug refractory epilepsy
Failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
Time frame: 3 years
All-cause mortality
Death caused by all the causes
Time frame: 3 years
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