Evaluation of Role of Intraoperative Ultrasound in Gross Total Resection of Gliomas

Trial Title: Evaluation of Role of Intraoperative Ultrasound in Gross Total Resection of Gliomas

NCT ID: NCT05707728

Condition: Glioma

Conditions: Official terms:
Glioma

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: intraoperative ultrasound
Description: intraoperative cranial ultrasound
Arm group label: totally resection of glioma using intraoperative ultrasound

Summary: The use of intraoperative ultrasound (IOUS )seems to have significantly increased the Gross total Resection rate achieved in brain gliomas surgery. As regard intraoperative visualisation of the tumor and its residuals, the effectiveness of IOUS has been documented in a series of 192 High Grade glioma patients, in which the combination of neuronavigation and IOUS was also related to increased overall survival in a prospective study of 32 patients, documented a good level of agreement between intraoperative ultrasonography and postoperative contrast-enhanced MRI in detecting tumor residuel they concluded that the IOUS produces results similar to those of MRI, and therefore, can be used to maximize tumor resection.

Detailed description: The use of intraoperative ultrasound (IOUS) during neurosurgical procedures was first described in 1978 by MH Reid The initial interest towards US as an imaging tool in neurosurgery progressively weaned from the 80's until the early 2000's in favor of other imaging techniques such as CT and MRI Maximal safe resection represents the gold standard for surgery of malignant brain tumors: gross total resection of the tumor while preserving the surrounding functional brain tissue is the main goal, since it is associated with longer survival and better patient quality of life This is particularly true for gliomas, the most common primary malignant brain tumors Concerning gross total resection, accurate localization and precise delineation of the tumor margins are required in order to avoid devastating lesions on nervous structures Ultrasound may provide an alternative tool to intraoperative magnetic resonance imaging (MRI) for delineating tumor Tissues and improving the chances of gross total resection The purpose of brain tumor removal is maximal resection while sparing healthy tissues. The extent of resection is a key prognostic factor in survival time, functional recovery, and tumor recurrence rates The optimal results of brain lesion surgery may be achieved by maximal surgical resection without disturbance of neurological functions Due to the imprecise correlation between preoperative images,intraoperative anatomy, and also poor differentiation of some tumors from a normal tissue, better delineation of normal from tumor tissue intraoperatively could improve clinical outcome as increasing chance of total resection and decreasing normal tissue damage . Intraoperative imaging technology increases the extent of tumor resection and patients' outcome including survival time. Intraoperative MRI are time-consuming and of high cost. Computed tomography (CT) usually is not of choice as ionizing radiation and limited mass delineation. Several researches have demonstrated that the image quality of ultrasound has improved enough to visualize and guide tumor resection The most important disadvantage of neuronavigation is the inconsistency with preoperative images from changes of the lesion and critical anatomic structures associated with brain shift as intraoperative tumor resection or cerebrospinal fluid drainage. This creates the need for updating the preoperative image with the intraoperative image The use of intraoperative ultrasound (IOUS )seems to have significantly increased the Gross total Resection rate achieved in brain gliomas surgery. As regard intraoperative visualisation of the tumor and its residuals, the effectiveness of IOUS has been documented in a series of 192 High Grade glioma patients, in which the combination of neuronavigation and IOUS was also related to increased overall survival in a prospective study of 32 patients, documented a good level of agreement between intraoperative ultrasonography and postoperative contrast-enhanced MRI in detecting tumor residuel they concluded that the IOUS produces results similar to those of MRI, and therefore, can be used to maximize tumor resection.

Criteria for eligibility:

Study pop:
Patients with all grades of gliomas confirmed by MRI any age and any sex

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: - Patients with all grades of gliomas confirmed by MRI , MRI with contrast and MR spectroscopy . - Age of the patient: any age. - Both sex Exclusion Criteria: - • Other tumours and space occupying lesion (sol) rather than gliomas confirmed by histopathology and preoperative imaging - Patients unfit for surgery

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Start date: March 2023

Completion date: October 2024

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05707728