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临床试验/NCT02723214
NCT02723214已完成不适用

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

University Hospital of Patras0 个研究点目标入组 56 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
主要终点
Diagnostic result

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Pediatric patients, 2) Coagulation abnormalities, 3) destructive comorbidities and very short life expectancy.

结局指标

主要结局

Diagnostic result

时间窗: One month postoperatively

Diagnostic yield, Histological - cytological evaluation of the biopsy specimens

Complications

时间窗: One month postoperatively

Neurologic morbidity, New abnormal findings in the postoperative head CT scan

次要结局

  • Length of hospitalization(One month postoperatively)
  • Duration of the whole procedure or steps(Immediately postoperatively)

研究者

发起方
University Hospital of Patras
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miltiadis Georgiopoulos

Dr

University Hospital of Patras

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