Intra-operative Variation in Size of Brain Tumors After Craniotomy

Sponsor

Sheri Kashmir Institute of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04365647

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Tumor dimension change [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 Outcome Measures

Tumor distance from dural surface [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
Relationship of tumor size change with other characteristics [March 2018 to November 2019]
Relationship of tumor size change with tumor consistency, tumor characteristics, histopathology, tumor location

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.