Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,200
- Locations
- 7
- Primary Endpoint
- neural function deterioration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Traditional microsurgery group
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.
Intervention: Traditional microsurgical operation (Procedure)
Hybrid operation group
Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.
Intervention: one-staged hybrid operation (Procedure)
Outcomes
Primary Outcomes
neural function deterioration
Time Frame: 3 months after operation
Increasing of mRS and mRS\>2
Secondary Outcomes
- postoperative mortality(7 days after operation)
- operation-related complications(7 days after operation)
- neural function deterioration in 12 months(12 months after operation)
- neural function deterioration in 6 months(6 months after operation)
- postoperative bAVMs residue(7 days after operation)
- 3 months bAVMs residue(3 months after operation)
- 6 months bAVMs residue(6 months after operation)
- 12 months bAVMs residue(12 months after operation)
Investigators
Shuo Wang
Director of Neurosurgery Department
Ministry of Science and Technology of the People´s Republic of China