A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Diagnostic yield
研究概览
简要总结
This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.
详细描述
AW frame is a stereotactic biopsy frame created by Dr. Albert Sii Hieng Wong. A phantom study had completed by Dr. Bik Liang Lau and Dr. Albert Sii Hieng Wong in year 2017 with good accuracy. The phantom study result is going to be submitted for publication by early 2019.
With the good accuracy of AW frame in the phantom study, the frame has been approved by the Medical Research & ethic committee (MREC) for human use in a research setting.
In the study, patient with intracranial lesion which required biopsy, whom fulfilled the criteria will be recruited. All these patient will underwent standard biopsy procedure either under local or general anaesthesia with AW frame mounted.
A localisation CT scanning will be perform with localiser fixed onto the head frame. Target of the intracranial lesion is selected. The coordinates of the localizing points and the selected target inserted into the AW stereo-calculator to generate the AW frame setting up measurements.
Burr hole will be performed and biopsy taken by using Nashold® biopsy needle. An immediate post-biopsy CT imaging will be performed to confirm the site of the biopsy. Patient will be monitored in the neurosurgery ward for any complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >17 years old
- •Radiological diagnosis of intracranial space occupying lesion of any etiology
排除标准
- •Patient involved in other study trial
- •Any serious medical condition that according to the investigator could interfere with the conduct of the study
- •Unwillingness or inability to comply with study requirements
结局指标
主要结局
Diagnostic yield
时间窗: For each patient 2 week after the biopsy
The diagnostic yield is defined as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the biopsy.
Number of participants presenting with post-biopsy complications
时间窗: an average of 2 week
The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the biopsy, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological evidence.
次要结局
- Time(From the time of the participant is transferred to the OR until the time of the participant transfer out of it, assessed on the day of operation.)
- Length of hospital stay(an average of 1 week)
研究者
Lau Bik Liang
Dr.
Ministry of Health, Malaysia