Arteriovenous Malformations, Cerebrovascular Disease, Complex; Primary
Conditions
Keywords
brain arteriovenous malformations, one-staged hybrid operation
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.
Interventions
PROCEDUREone-staged hybrid operation
An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.
PROCEDURETraditional microsurgical operation
The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neural function deterioration | 3 months after operation | Increasing of mRS and mRS\>2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| neural function deterioration in 12 months | 12 months after operation | Increasing of mRS and mRS\>2 |
| postoperative mortality | 7 days after operation | the fatality due to operation |
| operation-related complications | 7 days after operation | any complications that occur within 7 days from the date of operation, including intracranial hemorrhage or infarction, infection of the central nervous system, infection of the respiratory system, cranial nerve deficits, and other symptomatic complications |
| neural function deterioration in 6 months | 6 months after operation | Increasing of mRS and mRS\>2 |
| 3 months bAVMs residue | 3 months after operation | the bAVMs residue revealed by postoperative DSA or computed tomographic angiography |
| 6 months bAVMs residue | 6 months after operation | the bAVMs residue revealed by postoperative DSA or computed tomographic angiography |
| 12 months bAVMs residue | 12 months after operation | the bAVMs residue revealed by postoperative DSA or computed tomographic angiography |
| postoperative bAVMs residue | 7 days after operation | the bAVMs residue revealed by postoperative DSA or computed tomographic angiography |
Countries
China
Contacts
Primary ContactShuo Wang, MD
Backup ContactJun Wu, MD
Outcome results
None listed