Intra-operative Variation in Size of Brain Tumors After Craniotomy

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

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 Overview

• Status: Completed
• Conditions: Brain Tumor, Primary

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• India
  • Jammu And Kashmir
    • Srinagar, Jammu And Kashmir, India, 190011
      • Sher-i-Kashmir Institute of Medical Sciences, Soura

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 intracranial tumor surgery at our institute in the specified period.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Patient's in whom there is increase in tumor size after craniotomy
2; Patient's in whom there was either no increase in tumor size or decrease in tumor size after craniotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor dimension change	Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain	March 2018 to November 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor distance from dural surface	Change in the distance of tumor from dural surface as measured on intraoperative ultrasound when comparing it with pre-operative CEMRI and CECT brain	March 2018 to November 2019
Relationship of tumor size change with other characteristics	Relationship of tumor size change with tumor consistency, tumor characteristics, histopathology, tumor location	March 2018 to November 2019

Collaborators and Investigators

• Sponsor: Sheri Kashmir Institute of Medical Sciences
• Investigators: Principal Investigator: Abdul R Bhat, MCh, Sher-i-Kashmir Institute of Medical Sciences, Soura

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Glioblastoma multiforme; Gliomas; High grade glioma; Low grade glioma; Parenchymal brain tumors; Intraaxial brain tumors; Intraoperative Ultrasound (IOUS); Tumor Surfacing; Tumor expansion; Contrast enhanced magnetic resonance imaging (CEMRI) brain; Contrast enhanced computed tomography (CECT) brain
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: SKIMS, Soura

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No