Role of Intraoperative Fluorescein Sodium in resection of Intracranial High-Grade Gliomas.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is the residual tumor volume following resection in the fluorescein and non-fluorescein group.
研究概览
简要总结
Gliomas are primary brain tumors of the central nervous system. Glioblastomas are the most common and aggressive type of gliomas associated with very poor prognosis. A strong correlation exists between the extent of removal of glioblastomas and the overall survival. Similarity of the tumor tissue with the surrounding brain parenchyma makes complete resection quite challenging. Fluorescein sodium may serve as a promising aid in intraoperative identification of tumor tissue and hence increasing the chances of complete resection. This study is conducted to see the results of fluorescein sodium in guiding the extent of tumor removal.
This is a prospective observational study where patients fulfilling the study criteria will be included. In all cases, pre-operative MRI will be done within 7 days before surgery. The patients will be divided into two groups- a) Fluorescein group (FG) and b) Non-Fluorescein group(NFG). The patients who give consent for the use of fluorescein dye will be included in the fluorescein group, whereas the patients who don’t give consent for the use of this dye will be included in the non-fluorescein group. In FG the stained margins under Yellow 560 filter of the operating microscope will act as a guide in resection of the tumor, whereas patients in the NFG will undergo resection under the conventional white light microscope. Any adverse effects of the fluorescein dye will be recorded. Post-operative scans (MRI with contrast) will be done within 48 hours to see the extent of resection and check for residual tumor volume. Patients will be followed up for a period of 3 months (4 weeks and 3 months) to assess the quality of life.
•Residual tumor volumes will be only defined as lesions having a maximum diameter and a vertical measurement of >1 cm.
•Any adverse effects as a result of dye injection will be recorded.
•Post-operatively patients will be followed up for a period of 3 months (4 weeks and 3 months) to check for any disease recurrence.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients whose imaging shows features of high-grade gliomas.
- •Patients with high-grade gliomas where complete resection is planned pre-operatively.
排除标准
- •Patients with high-grade gliomas where complete resection is not planned (e.g. tumors in the eloquent areas, brainstem, thalamus, basal ganglia).
- •Patients who are unfit for surgery.
- •Histological diagnosis other than glioma.
- •Patients not willing to participate in the study.
结局指标
主要结局
The primary outcome of the study is the residual tumor volume following resection in the fluorescein and non-fluorescein group.
时间窗: Post-operative contrast MRI will be done within 48 hours of resection to check for residual tumor volume.
次要结局
- The secondary outcome of the study is the quality of life of the patients following surgery.(Patients will be followed up for a period of 3 months.)
研究者
RAHUL SAIKIA
Institute of Neurosciences, Kolkata