Surgical management of complex brain arteriovenous malformations with hybrid operating technique: study protocol of a prospective registry and a pragmatic clinical trial

BACKGROUND: 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. METHODS: The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation centers. 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. DISCUSSION: The study is designed for a real-world exploration of benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs. The two-set design reduces the compromise of clinical practice due to the study and improves the statistical power and research quality with a practical sample size. In the study, advantages of the one-staged hybrid operation will be evaluated and compared to those of traditional operation. A spanning development of neurosurgical operation might be facilitated by the study, which means a higher cure rate and lower disability rate in patients with complex bAVMs. TRIAL REGISTRATION: The study was retrospectively registered in ClinicalTrials.gov (NCT03774017) on 11th Dec, 2018.