Intra-operative Variation in Size of Brain Tumors After Craniotomy

Brain Tumor, Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365647
• Other study ID #: SKIMS, Soura
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: Sheri Kashmir Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 31, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Primary

Locations

Country	Name	City	State
India	Sher-i-Kashmir Institute of Medical Sciences, Soura	Srinagar	Jammu And Kashmir

Sponsors (1)

Lead Sponsor	Collaborator
Sheri Kashmir Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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