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

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ClinicalTrials.gov Identifier: NCT02723214
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Miltiadis Georgiopoulos, University Hospital of Patras

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lesion of Brain Procedure: Brain biopsy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Efficacy, Safety, Duration and Postoperative Hospitalization Between a Frameless Fiducial-less Brain Biopsy Method and the Standard Frame-based Stereotactic Biopsy
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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.




Primary Outcome Measures :
  1. Diagnostic result [ Time Frame: One month postoperatively ]
    Diagnostic yield, Histological - cytological evaluation of the biopsy specimens

  2. Complications [ Time Frame: One month postoperatively ]
    Neurologic morbidity, New abnormal findings in the postoperative head CT scan


Secondary Outcome Measures :
  1. Length of hospitalization [ Time Frame: One month postoperatively ]
  2. Duration of the whole procedure or steps [ Time Frame: Immediately postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723214


Sponsors and Collaborators
University Hospital of Patras
Investigators
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Study Director: Constantine Constantoyannis, MD, PhD Department of Neurosurgery, University Hospital of Patras, Faculty of Medicine, University of Patras

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Responsible Party: Miltiadis Georgiopoulos, Dr, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT02723214     History of Changes
Other Study ID Numbers: 5807212
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No