Intraoperative Brain Shift Calculation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Navigation-guided surgery.
- Who it may be relevant to
- Registry conditions: Tumor, Brain, Cavernoma, Arteriovenous Malformations, Intracerebral Hematoma. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
Overview
The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.
Detailed description
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.
Interventions
- Device Navigation-guided surgery
Surgeon removes brain lesions and assesses brain shift with neuronavigation
Primary outcome measures
- Brain shift (in millimeters) [Time frame: Intraoperatively]
Secondary outcome measures (2)
- Karnofsky Performance status in percents [Time frame: within 10 days after surgery]
- Cerebral complications [Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- rapid cerebral dislocation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Sklifosovsky Institute of Emergency Care — Moscow
Identifiers
NCT: NCT05477680 · 9e