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Intra-operative Variation in Size of Brain Tumors After Craniotomy

Intra-operative Variation in Size of Brain Tumors After Craniotomy - Observational Comparative Imaging Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04365647
Enrollment
51
Registered
2020-04-28
Start date
2018-03-01
Completion date
2020-03-31
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Primary

Keywords

Parenchymal brain tumors, Intraaxial brain tumors, Gliomas, Glioblastoma multiforme, Low grade glioma, High grade glioma, Intraoperative Ultrasound (IOUS), Tumor Surfacing, Tumor expansion, Contrast enhanced magnetic resonance imaging (CEMRI) brain, Contrast enhanced computed tomography (CECT) brain

Brief summary

We planned to evaluate the change in tumor dimensions of intraaxial parenchymal tumors after craniotomy by comparing the tumor size on intraoperative ultrasonography (IOUSG) with pre-operative CECT and CEMRI brain.

Detailed description

Background: No previous study to determine the intraoperative changes in the tumor dimensions had been undertaken previously. Objectives: We planned to evaluate the change in tumor dimensions of intraaxial parenchymal tumors after craniotomy by comparing the tumor size on intraoperative ultrasonography (IOUSG) with pre-operative CECT and CEMRI brain. Study Design: This was a prospective observational study. Participants: Patients aged 15-65 years undergoing surgery at SKIMS for intraaxial parenchymal intracranial tumors were included. Methods: Standard pre-operative CECT and CEMRI brain were done to measure tumor dimensions and compared with IOUSG.

Interventions

None listed

Sponsors

Sheri Kashmir Institute of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* All patients above the age of 15 years conferring to Grade I and II of American Society of Anesthesiologist (ASA) physical status classification system, undergoing elective craniotomy with intracranial tumor excision were included in this study. Patients with or without any neuro-deficit were also included. Only those patients in whom all the tumor dimensions could be defined with precision on pre-operative CECT, CEMRI and IOUSG were included in the final analysis.

Exclusion criteria

* Patients' in whom there are multiple intracranial tumors (e.g. metastasis), deep seated tumors, inability to use IOUSG and in whom exact tumor dimensions cannot be defined either on pre-operative CECT/CEMRI or on IOUSG were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Tumor dimension changeMarch 2018 to November 2019Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain

Secondary

MeasureTime frameDescription
Tumor distance from dural surfaceMarch 2018 to November 2019Change in the distance of tumor from dural surface as measured on intraoperative ultrasound when comparing it with pre-operative CEMRI and CECT brain
Relationship of tumor size change with other characteristicsMarch 2018 to November 2019Relationship of tumor size change with tumor consistency, tumor characteristics, histopathology, tumor location

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026