Spots Global Cancer Trial Database for Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
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Trial Identification
Brief Title: 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 ID: NCT03774017
Study Description
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
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Xuanwu Hospital, Capital Medical University, Beijing, Beijing, China
Beijing Tiantan Hospital Capital Medical University, Beijing, Beijing, China
General Hospital of Rocket Army, Beijing, Beijing, China
Qilu Hospital, Shandong University, Jinan, Shandong, China
Qingdao Municipal Hospital, Qingdao, Shandong, China
Huashan Hospital, Fudan University, Shanghai, Shanghai, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Contact Details
Name: Shuo Wang, MD
Affiliation: Beijing Tiantan Hospital
Role: PRINCIPAL_INVESTIGATOR
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