Clinical trial NCT05873946: Assessing the Effectiveness of 2D Non-Navigated Intraoperative Ultrasound in Glioma Surgery
Official title: Evaluating the Impact of 2D Non-Navigated Intraoperative Ultrasound on Extent of Resection and Patients' Outcome in Glioma Surgery: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Glioma, Malignant
Low-grade Glioma
High-grade Glioma
Glioblastoma
Keywords: Glioma
Low-grade glioma
High-grade glioma
intraoperative ultrasound
extent of resection
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this clinical trial will comprise of adult patients aged 18 years or older who have been diagnosed with gliomas. The population will likely reflect a diverse range of glioma types and stages, providing a comprehensive assessment of the effectiveness of the 2D non-navigated intraoperative ultrasound in the surgical management of these tumors.

Brief summary: This retrospective study aims to assess the utility of 2D non-navigated intraoperative ultrasound (ioUS) as a cost-effective alternative for guiding the surgical resection of gliomas and for detecting residual tumor. The study will analyse the records from consecutive adult patients diagnosed with gliomas, undergoing craniotomy between June 2018 and June 2023. The extent of resection (EOR) will be determined using postoperative MRI as the gold standard. The study will also examine the sensitivity and specificity of ioUS in detecting residual tumor. This research seeks to determine if ioUS can be an affordable and reliable tool that, combined with other intraoperative adjuncts, may aid neurosurgeons in achieving the maximum safe resection in glioma surgery.

Detailed description: Objective:

The objective of this retrospective study is to evaluate the effectiveness and utility of 2D non-navigated intraoperative ultrasound (ioUS) as a cost-effective method for guiding the surgical resection of gliomas and detecting residual tumor.

Methods:

The study will retrospectively analyze the records of consecutive adult patients diagnosed with gliomas who underwent craniotomy between June 2018 and June 2023. The patients' records must show that they underwent both intraoperative ultrasound and postoperative MRI.

Evaluation Criteria:

The primary evaluation metric will be the extent of resection (EOR), which will be determined using postoperative MRI scans as the gold standard. The EOR will be classified into gross total resection (GTR), near-total resection (NTR), subtotal resection (STR), and partial resection (PR) based on the MRI scans.

The study will also examine the sensitivity and specificity of ioUS in detecting residual tumor postoperatively. This analysis will help determine the accuracy of ioUS in predicting residual tumor that may not have been apparent during the surgical procedure.

Expected Outcomes:

The study aims to determine if ioUS can be a reliable and affordable tool for guiding the surgical resection of gliomas. If successful, ioUS, in conjunction with other intraoperative adjuncts, may provide a cost-effective method to aid neurosurgeons in achieving the maximum safe resection in glioma surgery.

The results of this study could have significant implications for the management of glioma patients, potentially leading to improved surgical outcomes, decreased postoperative complications, and ultimately, improved patient survival and quality of life.

The data collected from this retrospective analysis could also provide valuable insights for future prospective studies and could contribute to the development of guidelines for the use of ioUS in neurosurgery.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years or older.
* Patients diagnosed with gliomas, confirmed by a pathologist.
* Patients who are scheduled to undergo craniotomy for tumor resection.
* Patients who are willing and able to give informed consent for participation in the trial.
* Patients who are capable of undergoing both intraoperative ultrasound and postoperative MRI.

Exclusion Criteria:

* Patients under the age of 18.
* Patients with non-glioma brain tumors.
* Patients who underwent stereotactic biopsies.
* Patients who are unable to provide informed consent due to cognitive impairment, language barriers, or any other reason.
* Patients with contraindications for MRI such as certain types of implanted medical devices, severe claustrophobia, or allergies to contrast material.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Extent of tumor resection
timeFrame: 24 hours after the surgery
Secondary outcomes:
measure: Postoperative neurological deficit
timeFrame: From 24 hours to 30 days after the surgery
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: University Hospital Rio Hortega
Study officials:
affiliation: Department of Neurosurgery, Río Hortega University Hospital
name: Santiago Cepeda, MD.,PhD.
role: PRINCIPAL_INVESTIGATOR
References: