Clinical trial NCT04593966: Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes
Official title: Differences of Long-term Neurofunctional Outcomes in Pediatric and Adult Eloquent Region Cerebral Arteriovenous Malformation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Arteriovenous Malformation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
First posted: 2020-10-20
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with brain arteriovenous malformation which located in eloquent area.

Brief summary: Cerebral Arteriovenous malformations (AVMs) are abnormal tangles which are usually believed congenital. AVM can cause different symptoms depending on where it is located, but the most common symptoms are intracranial hemorrhage and seizure. Outcomes of AVM patients can be very different due to factors like the location of lesion, age, sex etc. Generally, more early the intervention was taken, the risk of adverse events would be lower. But the selection of surgical timing for pediatric AVM patients is hard to judge, due to children's cerebral vessels angioarchitecture can be still developing with their age. Some previous studies indicated that there is no difference in intervention outcomes between pediatric and adult AVM patients, so pediatric patients should undergo more aggressive intervention. DOPA study aims to compare the clinical intervention outcomes of both pediatric and adult patients with eloquent region cerebral arteriovenous malformations, helping to determine the treatment strategy.

Detailed description: Follow-up: In the investigators' neurosurgical center, follow-up was conducted for all participants at the first 3-6 months and annually after discharge by clinical visit and telephone interview.

Study overview: DOPA will aim on outcomes of both pediatric and adult AVMs patients who underwent intervention in investigators' institution. Intervention strategies contains microsurgical resection, embolization, embolization + radiosurgery, and single-stage hybrid surgery (embolization + resection). Outcomes will be measured by a neurologist using Modified Rankin Scale (mRs). Participants' mRs\<2 will be considered as a good outcome and investigators will keep follow-up with every patient for at least 3 years.

Sample size: About 300 patients will be enrolled in this study, and adults and children will account for half. All kinds of intervention will be included. The distribution of different strategies is excepted as: 30% resection, 20% embolization, 30% embolization + radiosurgery and 20% hybrid surgery.

Study endpoints: The patients' mRs, occlusion rate and complication will be evaluated at 2 weeks, discharge from hospital, 1 year and 3 years after the first-time intervention.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
* Patients had underwent interventions in our institution.
* AVMs were located in eloquent area.

Exclusion Criteria:

* Patients with multiple AVMs.
* Patients with hereditary hemorrhagic telangiectasia (HHT).
* Patients with missing clinical and imaging data.

Primary outcomes:
measure: modified Ranking Scale score at 2 weeks after the operation
timeFrame: 2 weeks
measure: modified Ranking Scale score when discharge
timeFrame: Discharge (assessed up to 10 days)
measure: modified Ranking Scale score at 1 years after the operation
timeFrame: 1 years
measure: modified Ranking Scale score at 3 years after the operation
timeFrame: 3 years
Secondary outcomes:
measure: Obliteration rate
timeFrame: At least 1 year, up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital medical university affiliated Beijing Tiantan hospital
state: Beijing
Study officials:
References: