Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations

Conditions
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Cerebrovascular Disease, Arteriovenous Malformations, Complex; Primary

Intervention / Treatment
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* Procedure: one-staged hybrid operation
* Procedure: Traditional microsurgical operation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of all ages; diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula; 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; with Spetzler-Martin Grades from I to IV; who provide informed consent. Exclusion Criteria: >70 years old with no significant hemorrhagic risk of bAVMs; with Spetzler-Martin Grade ≥V; accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation; allergic to iodinated contrast agent; unable to give informed consent.

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Traditional microsurgery group<br>Patients receive only traditional microsurgical operations in traditional operating theaters or the one-staged hybrid operation theater. No endovascular intervention technique or intraoperative digital subtraction angiography(DSA) will be performed. The DSA will be performed in 3 days after the operation. | Procedure: Traditional microsurgical operation<br>* 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<br>|
| Experimental: Hybrid operation group<br>Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater. | Procedure: one-staged hybrid operation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neural function deterioration | Increasing of mRS and mRS>2 | 3 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neural function deterioration in 6 months | Increasing of mRS and mRS>2 | 6 months after operation | 
| neural function deterioration in 12 months | Increasing of mRS and mRS>2 | 12 months after operation | 
| postoperative mortality | the fatality due to operation | 7 days after operation | 
| operation-related complications | 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 | 7 days after operation | 
| postoperative bAVMs residue | the bAVMs residue revealed by postoperative DSA or computed tomographic angiography | 7 days after operation | 
| 3 months bAVMs residue | the bAVMs residue revealed by postoperative DSA or computed tomographic angiography | 3 months after operation | 
| 6 months bAVMs residue | the bAVMs residue revealed by postoperative DSA or computed tomographic angiography | 6 months after operation | 
| 12 months bAVMs residue | the bAVMs residue revealed by postoperative DSA or computed tomographic angiography | 12 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain arteriovenous malformations, one-staged hybrid operation