Clinical trial NCT03774017: Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
Official title: Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Disease
Arteriovenous Malformations
Complex; Primary
Keywords: brain arteriovenous malformations
one-staged hybrid operation
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
First posted: 2018-12-12
Enrollment: 1200
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of neural function deterioration. The multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. The one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bAVMs. However, lacking the support of high-level evidence, its advantages remain unclear. This study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its indications, key technologies, and workflows.

Detailed description: The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists of 2 sets. The registry set is designed as a prospective real-world registry. The trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. The two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. The assignment is based on the clinical condition in the registry set and is randomized in the trial set. End points will be evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation in treating complex bAVMs will be validated.

Eligibility criteria: Inclusion Criteria:

1. patients of all ages;
2. diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;
3. with any operative indications as follows: (1) with stable hematoma or history of hemorrhage due to bAVMs, and allowed selective operation; (2) with recurrent epilepsy seizure, having failed treatment with antiepileptic drugs (AEDs); (3) with induced deterioration of neurological functions;
4. with Spetzler-Martin Grades from I to IV;
5. who provide informed consent.

Exclusion Criteria:

1. \>70 years old with no significant hemorrhagic risk of bAVMs;
2. with Spetzler-Martin Grade ≥V;
3. accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation;
4. allergic to iodinated contrast agent;
5. unable to give informed consent.

Primary outcomes:
measure: neural function deterioration
timeFrame: 3 months after operation
Secondary outcomes:
measure: neural function deterioration in 6 months
timeFrame: 6 months after operation
measure: neural function deterioration in 12 months
timeFrame: 12 months after operation
measure: postoperative mortality
timeFrame: 7 days after operation
measure: operation-related complications
timeFrame: 7 days after operation
measure: postoperative bAVMs residue
timeFrame: 7 days after operation
measure: 3 months bAVMs residue
timeFrame: 3 months after operation
measure: 6 months bAVMs residue
timeFrame: 6 months after operation
measure: 12 months bAVMs residue
timeFrame: 12 months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: General Hospital of Rocket Army
state: Beijing
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shuo Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang M, Qiu H, Cao Y, Wang S, Zhao J. One-staged in situ embolization combined with surgical resection for eloquence protection of AVM: technical note. Neurosurg Rev. 2019 Sep;42(3):783-790. doi: 10.1007/s10143-019-01137-w. Epub 2019 Jul 30.
citation: Wang M, Jiao Y, Cao Y, Wang S, Zhao J. Surgical management of complex brain arteriovenous malformations with hybrid operating technique: study protocol of a prospective registry and a pragmatic clinical trial. BMC Neurol. 2019 Apr 30;19(1):75. doi: 10.1186/s12883-019-1289-3.