Sonography-guided Resection of Brain Mass Lesions: 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
- 2
- 主要终点
- Ultrasound features of various brain mass lesions in Mair scale (in grades)
研究概览
简要总结
Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.
详细描述
Intraoperative sonography is usially used in neurooncology to detect brain tumors and exclude their remnants. A few studies describe it's usage while removing hematomas or vascular malformations. Ultrasound is the only method allowing to observe brain tissue in real time. It is chip and doesn't violate surgical workflow. Main disadvantages of sonography are lengthy learning curve and poorer image quality compared to magnetic resonance imaging. Novel acoustic coupling fluid, contrast-enhanced ultrasound and elastography expanded it's effectiveness. Meanwhile problems of locating of isoechogenic lesions with poor margins and elimination of artefacts are steel actual.
Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.
A surgeon will intraoperatively locate mass lesion and assess extent of it's resection with sonography. Ultrasound scanning will be performed through the same surgical approach or at a distance through enlarged craniotomy, periodically or permanently. To facilitate approach to subcortical and deep small mass lesions ultrasound-guided needle or ultrasound wire-guided port will be used.
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
排除标准
- •rapid cerebral dislocation
- •previously performed brain radiotherapy
结局指标
主要结局
Ultrasound features of various brain mass lesions in Mair scale (in grades)
时间窗: Intraoperatively
Assessment of target visibility, echogenicity, homogeneity and border demarcation in sonography and their comparison to preoperative computed tomography and magnetic resonance imaging
次要结局
- Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents)(Intraoperatively)
- Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes)(Intraoperatively)
- Duration of mass lesion removal (in minutes)(Intraoperatively)
- Differentiation between artefacts and residual lesion (Yes or No)(Intraoperatively)
- Negative predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)(Within 48 hours after surgery)
- Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents)(Within 48 hours after surgery)
- Accuracy of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)(Within 48 hours after surgery)
- Specificity of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)(Within 48 hours after surgery)
- Positive predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents)(Within 48 hours after surgery)
- Extent of resection (in percents)(Within 48 hours after surgery)
- 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