Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Brain shift (in millimeters)
研究概览
简要总结
The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.
详细描述
Brain shift is the main natural cause of major navigation imprecision. Despite numerous attempts no trials showed a possibility to calculate and predict it's value although some patterns were found. Some modern navigational features allow to partially resolve this problem. Manual shift correction allows to displace brain structures but can only be used if brain shift is linear. Intraoperative computed tomography (CT) and magnetic resonance imaging (MRI) allow to update navigational data but violate surgical workflow and cannot display brain tissue in real time. Intraoperative sonography has poorer quality, limited observe volume and lengthy learning curve.
The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.
For each patient a surgeon intraoperatively will assess location of brain surface, various intracranial structures and lesion margins during surgery. Postoperatively these data will be compared to lesion's characteristics, patient's state and intraoperative features.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all intracranial tumors
- •cavernomas
- •arteriovenous malformations
- •spontaneous (non-traumatic) intracerebral hemorrhages
- •traumatic intracerebral hemorrhages
- •supratentorial localization
- •newly diagnosed
- •age 18-100 years
- •stable hemodynamics
- •error of patient registration in neuronavigation no more than 2 mm
排除标准
- •rapid cerebral dislocation
研究组 & 干预措施
Surgery
Removing different brain lesions using neuronavigation
干预措施: Navigation-guided surgery (Device)
结局指标
主要结局
Brain shift (in millimeters)
时间窗: Intraoperatively
Maximal difference between disposition of different brain structures in preoperative scans and it's real intraoperative location
次要结局
- Karnofsky Performance status in percents(within 10 days after surgery)
- Cerebral complications(From admission to intensive care unit after surgery till hospital discharge, up to 365 days)
研究者
Alexander Dmitriev
Principal Investigator
Sklifosovsky Institute of Emergency Care
