跳至主要内容
临床试验/NCT05477680
NCT05477680招募中不适用

Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial

Sklifosovsky Institute of Emergency Care1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

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

Experimental

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

发起方
Sklifosovsky Institute of Emergency Care
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alexander Dmitriev

Principal Investigator

Sklifosovsky Institute of Emergency Care

研究点 (1)

Loading locations...

相似试验