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Completed

NCT Number: NCT02723214

Comparison of Parameters Between a Frameless 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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain biopsy

Procedure

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 outcomes

  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 outcomes

  1. Length of hospitalization

    Time frame: One month postoperatively

  2. Duration of the whole procedure or steps

    Time frame: Immediately postoperatively

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Mar 30, 2016
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.