Tumor, Brain, Arteriovenous Malformations, Cavernoma, Intracerebral Hematoma
Conditions
Keywords
intraoperative sonography, intraoperative ultrasound, brain tumor, cavernoma, arteriovenous malformation, intracerebral hematoma
Brief summary
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.
Detailed description
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.
Interventions
DEVICESonography
Surgeon detects brain mass lesion and assesses extent of it's resection with sonography
Sponsors
Sklifosovsky Institute of Emergency Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Exclusion criteria
* rapid cerebral dislocation * previously performed brain radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound features of various brain mass lesions in Mair scale (in grades) | Intraoperatively | Assessment of target visibility, echogenicity, homogeneity and border demarcation in sonography and their comparison to preoperative computed tomography and magnetic resonance imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents) | Intraoperatively | Sensitivity = true detection of mass lesion / (true detection of mass lesion + inability to detect mass lesion) x 100 |
| 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 | Sensitivity = true detection of residual mass lesion / (true detection of residual mass lesion + inability to detect residual mass lesion) x 100 |
| 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 | Specificity = true absence of residual mass lesion / (true absence of residual mass lesion + false detection of residual mass lesion) x 100 |
| 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 | Positive predictive value = true detection of residual mass lesion / (true detection of residual mass lesion + false detection of residual mass lesion) x 100 |
| 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 | Negative predictive value = true absence of residual mass lesion / (true absence of residual mass lesion + inability to detect residual mass lesion) x 100 |
| Duration of mass lesion removal (in minutes) | Intraoperatively | How long did in take to remove mass lesion from starting of it's dissection till final evacuation |
| Extent of resection (in percents) | Within 48 hours after surgery | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 |
| Differentiation between artefacts and residual lesion (Yes or No) | Intraoperatively | Possibility of ultrasound differentiation between artefacts and residual lesion |
| Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes) | Intraoperatively | Only for subcortical or deep-seated mass lesions. How long did in take to reach margin of mass lesion after dural incision using ultrasound-guided needle or ultrasound wire-guided port |
| Karnofsky performance status (in percents) | Within 10 days after surgery | Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale |
| Cerebral complications | From admission to intensive care unit after surgery till hospital discharge, up to 365 days | Which cerebral complications arose 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 | Accuracy = (true detection of residual mass lesion + true absence of residual mass lesion) / (true detection of residual mass lesion + true absence of residual mass lesion + false detection of residual mass lesion + inability to detect residual mass lesion) x 100 |
Countries
Russia
Contacts
Primary ContactAlexander Dmitriev, MD
Outcome results
None listed