Clinical trial NCT04365647: Intra-operative Variation in Size of Brain Tumors After Craniotomy
Official title: Intra-operative Variation in Size of Brain Tumors After Craniotomy - Observational Comparative Imaging Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Sheri Kashmir Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 51
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor dimension change
timeFrame: March 2018 to November 2019
Secondary outcomes:
measure: Tumor distance from dural surface
timeFrame: March 2018 to November 2019
measure: Relationship of tumor size change with other characteristics
timeFrame: March 2018 to November 2019
Other outcomes:
Locations:
city: Srinagar
country: India
facility: Sher-i-Kashmir Institute of Medical Sciences, Soura
state: Jammu And Kashmir
Study officials:
affiliation: Sher-i-Kashmir Institute of Medical Sciences, Soura
name: Abdul R Bhat, MCh
role: PRINCIPAL_INVESTIGATOR
References: