Preoperative Embolization for Highly Vascularised Intracranial Tumors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 主要终点
- Number of Participants Achieving Defined Grades of Tumor Devascularization
研究概览
简要总结
Highly vascular brain tumors, including meningiomas, hemangioblastomas, and certain metastases, have a rich blood supply that can lead to substantial blood loss and technical difficulties during surgical removal. Preoperative endovascular embolization is an adjunctive, catheter-based procedure used to block the feeding blood vessels of the tumor before surgery, aiming to reduce intraoperative bleeding and facilitate safer tumor resection.
The primary purpose of this study is to evaluate the technical feasibility, safety, and effectiveness of preoperative endovascular embolization in patients with highly vascular intracranial tumors.
Participants enrolled in this prospective study will undergo:
- Pre-procedural neurological and diagnostic cross-sectional imaging (contrast-enhanced MRI or CT angiography).
- Diagnostic digital subtraction angiography (DSA) to map tumor-feeding arteries, followed by super-selective catheterization to deliver embolic materials (polyvinyl alcohol particles, Onyx, or microcoils).
- Microsurgical tumor resection within 24 to 72 hours following the embolization procedure.
Researchers will assess the degree of tumor devascularization achieved, the volume of intraoperative blood loss, blood transfusion requirements, total surgical duration, extent of tumor resection, and the occurrence of any procedure-related 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
- Treatment
- 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
- •Diagnosis of a hypervascular brain tumor (e.g., meningioma, hemangioblastoma, or hypervascular metastasis) confirmed by contrast-enhanced MRI or CT
- •Scheduled for preoperative endovascular embolization followed by microsurgical resection
排除标准
- •Severe, uncorrected coagulopathy
- •Severe allergy to iodinated contrast media
- •Severe renal insufficiency (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m²)
- •Absence of safe arterial access
- •Absence of identifiable tumor-feeding vessels suitable for selective microcatheterization
研究组 & 干预措施
Preoperative Embolization and Surgical Resection
Participants undergo pre-procedural neurological and imaging assessment, followed by diagnostic digital subtraction angiography (DSA) to identify tumor-feeding vessels. Super-selective microcatheterization is performed to deliver embolic agents (polyvinyl alcohol [PVA] particles, Onyx, or microcoils) for tumor devascularization. Post-embolization devascularization is evaluated by repeat DSA/CT, followed by microsurgical tumor resection within 24 to 72 hours.
干预措施: Preoperative Endovascular Embolization (Procedure)
结局指标
主要结局
Number of Participants Achieving Defined Grades of Tumor Devascularization
时间窗: 24 hours post-embolization
Tumor devascularization is determined by comparing post-embolization digital subtraction angiography (DSA) or CT angiography against baseline diagnostic imaging. Participants are categorized into three predefined grades based on devascularization of tumor vascular blush: poor (\<50%), moderate (50% to 80%), or good/complete (\>80%).
次要结局
未报告次要终点
研究者
Sara Bakhet Abd Elrassol Saleh
Resident of Diagnostic and Interventional Radiology
Assiut University