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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
ultrasound scanning of brain to search tumor remnants
Sklifosovsky Institute of Emergency Care
Moscow, Russia
Extent of resection in percents
Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100
Time frame: within 48 hours after surgery
Gross total resection (Yes or No)
Gross total resection is a total removal of tumor (or 100 percents extent of resection)
Time frame: within 48 hours after surgery
Motor function (in grades)
Motor function is assessed in Medical Research Council scale
Time frame: within 10 days after surgery
Speech function (in grades)
Speech function is assessed in Hendrix scale (2017)
Time frame: within 10 days after surgery
Karnofsky Performance status in percents
Assesses patients' possibilities to self-service
Time frame: within 10 days after surgery
Cerebral complications
Which cerebral complications arose after surgery
Time frame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
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