Introduction There are two approaches for the treatment of intracranial aneurysm (IA): interventional therapy and craniotomy, both of which have their advantages and disadvantages in terms of treatment efficacy. To avoid overtreatment of unruptured aneurysms (UIA), to save valuable medical resources and to reduce patient mortality and disability rate, it is vital that neurosurgeons select the most appropriate type of treatment to provide the best levels of care. In this study, we propose a refined, prospective, multicentre study for the Chinese population with strictly defined patient inclusion criteria, along with the selection of representative clinical participating centres.
Methods and analysis This report describes a multicentre, prospective cohort study. As IA is extremely harmful if it ruptures, ethical issues need to be taken into account with regard to this study. Researchers are therefore not able to use randomised controlled trials. The study will be conducted by 12 clinical centres located in different regions of China. The trial recruitment programme begins in 2016 and is scheduled to be completed in 2020. We expect 1500 participants with UIA to be included. Clinical information relating to the participants will be recorded objectively. The primary endpoints are an evaluation of the safety and efficiency of interventional treatment and craniotomy for 6 months after surgery, with each participant completing at least 1 year of follow-up. The secondary endpoint is the evaluation of safety and efficacy of interventional therapy and craniotomy clipping when participants are treated for 12 months. We also address the success of treatment and the incidence of adverse events.
Ethics and dissemination The research protocol and the informed consent form for participants in this study were approved by the Ethics Committee of Zhujiang Hospital of Southern Medical University (2017-SJWK-001). The results of this study are expected to be disseminated in peer-reviewed journals in 2021.
Trial registration number NCT03133598.
- un-ruptured aneurysms
- interventional treatment
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Contributors CD obtained the research funding and is the principal investigator of this study. YC, HF, XL, MH, YQ, XY and HZ have developed the study protocol, and YC is the main author of this article. HF, XH, SG and XL have revised the manuscript. XS, LW, ZW, XT, MZ, AM and ZT are the main people responsible for the seven clinical centres and responsible for implementing this study. CD has approved publication of the final manuscript. YC, HF, XS, LW, ZW, XT, MZ, AM and ZT are responsible for recruitment of patients.
Funding This study was supported by the National Key Research Development Program (grants no 2016YFC1300804 and 2016YFC1300800) and the Specialized Research Fund for the Doctoral Program of Higher Education (grant no 20124433110014).
Competing interests None declared.
Patient consent Obtained.
Ethics approval The study protocol was approved by the Ethics Committee of Zhujiang Hospital of Southern Medical University (reference number: 2017-SJWK-001) and its respective Institutional Review Board.
Provenance and peer review Not commissioned; externally peer reviewed.
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