Intra-operative Variation in Size of Brain Tumors After Craniotomy

NCT04365647 | Completed DMC

• 1 other identifier: SKIMS, Soura
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tumor distance from dural surface

  March 2018 to November 2019

• Relationship of tumor size change with other characteristics

  March 2018 to November 2019

Study Arms (2)

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

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheri Kashmir Institute of Medical Sciences: lead

Study Sites (1)

Sher-i-Kashmir Institute of Medical Sciences, Soura

Srinagar, Jammu and Kashmir, 190011, India

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Study Officials

• Abdul R Bhat, MCh

  Sher-i-Kashmir Institute of Medical Sciences, Soura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: March 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: March 31, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)