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The purpose of the study is to determine whether intraoperative ultrasound guided resection of glioma without contrast enhancement in magnetic resonance imaging can achieve higher extent of resection than surgery without intraoperative sonography
Gliomas, not enhancing contrast agent in magnetic resonance imaging (MRI), are usually low-grade gliomas. They rarely show intraoperative fluorescence using 5-aminolevulinic acid or fluorescein. Intraoperative high-field MRI, sonography and navigation are the only ways to assess extent of their resection during surgery. MRI is the gold standard, but interrupts surgical workflow and only few hospitals are equipped with device like that. Navigation eventually looses it's precision due to brainshift. Ultrasound allows assess tumor remnants in real time but has worse imaging quality. Currently no randomized trials published their results about efficiency of intraoperative sonography in removing low-grade gliomas.
Objective of the study is to determine whether intraoperative ultrasound guided resection of non-enhancing gliomas can achieve higher extent of resection than surgery without intraoperative sonography.
Participants of the study will be randomly operated with and without intraoperative ultrasound. Extent of resection will be assessed in postoperative MRI by blinded radiologists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental | Glioma resection with intraoperative sonography |
|
| Non-ultrasound | No Intervention | Glioma resection without intraoperative sonography |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative sonography | Procedure | ultrasound scanning of brain to search tumor remnants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extent of resection in percents | Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100 | within 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Gross total resection (Yes or No) | Gross total resection is a total removal of tumor (or 100 percents extent of resection) | within 48 hours after surgery |
| Motor function (in grades) | Motor function is assessed in Medical Research Council scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Dmitriev, MD | Sklifosovsky Institute of Emergency Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sklifosovsky Institute of Emergency Care | Moscow | 129090 | Russia |
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Glioma extent of resection will be assessed by radiologists blinded for the treatment arm
| within 10 days after surgery |
| Speech function (in grades) | Speech function is assessed in Hendrix scale (2017) | within 10 days after surgery |
| Karnofsky Performance status in percents | Assesses patients' possibilities to self-service | within 10 days after surgery |
| Cerebral complications | Which cerebral complications arose after surgery | From admission to intensive care unit after surgery till hospital discharge, up to 365 days |