机构:[1]Department of Neurosurgery, Southern Medical University, Zhujiang Hospital, Guangzhou, China [2]Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, China [3]Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi’an, China [4]Department of Interventional Neuroradiology, Beijing Neurosurgical Institute and Beijing Tiantan Hospital, Capital Medical University, Beijing, China 重点科室医技科室研究所放射科放射科北京市神经外科研究所首都医科大学附属天坛医院[5]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China 神经科系统神经外科首都医科大学宣武医院[6]Department of Neurosurgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China [7]Department of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang, China [8]Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China [9]Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin, China [10]Department of Neurosurgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China [11]Department of Neurosurgery, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China [12]Department of Neurosurgery, The First Hospital of China Medical University, Shenyang, China
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.
基金:
National Key Research Development Program [2016YFC1300804, 2016YFC1300800]; Specialized Research Fund for the Doctoral Program of Higher Education [20124433110014]
第一作者机构:[1]Department of Neurosurgery, Southern Medical University, Zhujiang Hospital, Guangzhou, China
通讯作者:
通讯机构:[1]Department of Neurosurgery, Southern Medical University, Zhujiang Hospital, Guangzhou, China
推荐引用方式(GB/T 7714):
Yunchang Chen,Haiyan Fan,Xuying He,et al.China Intracranial Aneurysm Project (CIAP): protocol for a prospective coho study of interventional treatment and craniotomy for unruptured aneurysms[J].BMJ OPEN.2018,8(5):-.doi:10.1136/bmjopen-2017-019333.
APA:
Yunchang Chen,Haiyan Fan,Xuying He,Shenquan Guo,Xifeng Li...&Chuanzhi Duan.(2018).China Intracranial Aneurysm Project (CIAP): protocol for a prospective coho study of interventional treatment and craniotomy for unruptured aneurysms.BMJ OPEN,8,(5)
MLA:
Yunchang Chen,et al."China Intracranial Aneurysm Project (CIAP): protocol for a prospective coho study of interventional treatment and craniotomy for unruptured aneurysms".BMJ OPEN 8..5(2018):-