Comparison of Parameters Between a Frameless Brain Biopsy Method and the Standard Frame-based Stereotactic Biopsy

Comparison of Efficacy, Safety, Duration and Postoperative Hospitalization Between a Frameless Fiducial-less Brain Biopsy Method and the Standard Frame-based Stereotactic Biopsy

The purpose of the present study is to compare the characteristics, i.e. efficacy, duration, safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the standard frame-based stereotactic technique.

Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for open craniotomy.

Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless fiducial-less method using an optical based navigation system and a mini frame apparatus - trajectory guide.

Study Overview

• Status: Completed
• Conditions: Lesion of Brain
• Intervention / Treatment: Procedure: Brain biopsy

Detailed Description

The purpose of the present study is to compare the characteristics, i.e. efficacy, duration, safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the standard frame-based stereotactic technique, in order to apply a technique friendlier to the patient, more comfortable for the surgeon and more flexible concerning the overall hospital's function.

Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for open craniotomy.

Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless fiducial-less method using an optical based navigation system and a mini frame apparatus - trajectory guide.

The following parameters will be assessed: diagnostic yield, histological - cytological evaluation of the biopsy specimens, cerebral lesions' location, lesions' maximum diameter, duration of: the overall procedure, the preparatory steps overall, the preparation inside the OR, operation ("skin-to-skin"), the time spent inside the OR overall, neurologic morbidity, new abnormal findings in the postoperative head CT scan, length of hospitalization.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Patients: 1) for whom no conclusive diagnosis could be settled in a noninvasive manner; and 2 who also had surgically inaccessible lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the probable diagnosis is a contraindication for craniotomy.

Exclusion Criteria: 1) Pediatric patients, 2) Coagulation abnormalities, 3) destructive comorbidities and very short life expectancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Frame-based stereotactic brain biopsy; Brain biopsy	Procedure: Brain biopsy; Brain biopsy using either the frame-based stereotactic technique, or a frameless fiducial-less brain biopsy method using an optical based navigation system and a mini frame apparatus - trajectory guide.
Active Comparator: Frameless fiducial-less brain biopsy; Brain biopsy	Procedure: Brain biopsy; Brain biopsy using either the frame-based stereotactic technique, or a frameless fiducial-less brain biopsy method using an optical based navigation system and a mini frame apparatus - trajectory guide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic result	Diagnostic yield, Histological - cytological evaluation of the biopsy specimens	One month postoperatively
Complications	Neurologic morbidity, New abnormal findings in the postoperative head CT scan	One month postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospitalization	One month postoperatively
Duration of the whole procedure or steps	Immediately postoperatively

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Investigators: Study Director: Constantine Constantoyannis, MD, PhD, Department of Neurosurgery, University Hospital of Patras, Faculty of Medicine, University of Patras

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 5807212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO