Sonography-guided Resection of Brain Mass Lesions
- Conditions
- Tumor, BrainArteriovenous MalformationsIntracerebral HematomaCavernoma
- Interventions
- Device: Sonography
- Registration Number
- NCT05484245
- Lead Sponsor
- Sklifosovsky Institute of Emergency Care
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- all intracranial tumors
- cavernomas
- arteriovenous malformations
- spontaneous (non-traumatic) intracerebral hemorrhages
- traumatic intracerebral hemorrhages
- supratentorial localization
- newly diagnosed
- age 18-100 years
- stable hemodynamics
- rapid cerebral dislocation
- previously performed brain radiotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surgery Sonography Ultrasound-guided resection of brain tumors, vascular malformations and hematomas
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
Differentiation between artefacts and residual lesion (Yes or No) Intraoperatively Possibility of ultrasound differentiation between artefacts and residual lesion
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
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
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
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
Extent of resection (in percents) Within 48 hours after surgery Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
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
Trial Locations
- Locations (1)
Sklifosovsky Institute of Emergency Care
🇷🇺Moscow, Russian Federation