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NCT Number: NCT04365647

Intra-operative Variation in Size of Brain Tumors After Craniotomy

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.

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Key information

Conditions

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

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sher-i-Kashmir Institute of Medical Sciences, Soura

Srinagar, Jammu and Kashmir, 190011, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Tumor dimension change

    Time frame: March 2018 to November 2019

    Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain

Secondary outcomes

  1. Tumor distance from dural surface

    Time frame: March 2018 to November 2019

    Change in the distance of tumor from dural surface as measured on intraoperative ultrasound when comparing it with pre-operative CEMRI and CECT brain

  2. Relationship of tumor size change with other characteristics

    Time frame: March 2018 to November 2019

    Relationship of tumor size change with tumor consistency, tumor characteristics, histopathology, tumor location

Sponsors and collaborators

Lead sponsor

Sheri Kashmir Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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