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

NCT ID: NCT05707728

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2024-10-31

Brief 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.

Conditions

Glioma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

totally resection of glioma using intraoperative ultrasound

totally resection of glioma using intraoperative ultrasound

intraoperative ultrasound

Intervention Type: DEVICE

intraoperative cranial ultrasound

Interventions

intraoperative ultrasound

intraoperative cranial ultrasound

Intervention Type: DEVICE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Fadwa Ahmwd Ahmed

resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fadwa Ahmed Ahmed, resident

Role: CONTACT

Fadwa.ahmed5@gmail.com

0201002673946

shady abdelrahem hassan, Assistant professor

Role: CONTACT

Shadyhassaan86@yahoo.com

0201144344998

References

1. Giammalva, G.R.; Iacopino, D.G.; Azzarello, G.; Gaggiotti, C.; Graziano, F.; Gulì, C.; Pino, M.; Maugeri, R. End-of-Life Care in High-Grade Glioma Patients. The Palliative and Supportive Perspective. Brain Sci. 2018, 8, 125. [CrossRef] [PubMed] 2. La Torre, D.; Maugeri, R.; Angileri, F.F.; Pezzino, G.; Conti, A.; Cardali, S.M.; Calisto, A.; Sciarrone, G.; Misefari, A.; Germanò, A.; et al. Human leukocyte antigen frequency in human high-grade gliomas: A case-control study in Sicily. Neurosurgery 2009, 64, 1082-1088. [CrossRef] [PubMed] 3. Maugeri, R.; Schiera, G.; Di Liegro, C.M.; Fricano, A.; Iacopino, D.G.; Di Liegro, I. Aquaporins and brain tumors. Int. J. Mol. Sci. 2016, 17, 1029. [CrossRef] [PubMed] 4. Grasso, G.; Meli, F.; Fodale, V.; Calapai, G.; Buemi, M.; Iacopino, D.G. Neuroprotective potential of erythropoietin and darbepoetin alfa in an experimental model of sciatic nerve injury. J. Neurosurg. Spine 2007, 7, 645-651. [CrossRef] [PubMed] 5. Unsgaard G, Ommendal S, Muller T, Gronningsaeter A, Hernes TAN. Neuronavigation by intraoperative three-dimensional ultrasound: initial experience during brain tumor resection. Neurosurgery. 2002;50(4): 804-12. 6. Almenawer SA, Badhiwala JH, Alhazzani W, Greenspoon J, Farrokhyar F, Yarascavitch B, et al. Biopsy versus partial versus gross total resection in older patients with high-grade glioma: a systematic review and metaanalysis. Neuro Oncol. 2015;17(6):868-81. 7. Elserry TH, Anwer H, Radwan HA. Introduction of vaginal probe for intraoperative ultrasound of intra-axial brain lesions. Egyp J Neurosurg. 2013; 28(4):5-12. 8. Zhang ZZ, Shield LBE, Sun DA, Zhang YP, Hunt MA, Christopher BS. The art of intraoperative glioma identification. Front Oncol. 2015;5(175):1-7. 9. Gronningsaeter A, Kleven A, Ommedal S, Aarseth TE, Lie T, Lindseth F, Lango T, Unsgaar

Reference Type: BACKGROUND

Other Identifiers

intraoperative ultrasound

Identifier Type: -

Identifier Source: org_study_id