Study of Endoscopic Choroid Plexus Cauterization for Adult Patients With Hydrocephalus and Risk Factors for Perioperative Complications Following Shunt Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Occurrence of post-operative complications
研究概览
简要总结
The purpose of this study is to determine whether endoscopic choroid plexus coagulation is safe in adult patients with communicating hydrocephalus and risk factors for complications from the standard surgical treatment. It may also help determine whether the endoscopic choroid plexus coagulation is effective in treating your communicating hydrocephalus. The Investigators hope that this research will allow us to place fewer shunts in patients with conditions similar to yours, avoiding 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
- •Adult patients (age 18 or older) with communicating hydrocephalus, who have risk factors for complications following shunt surgery. Risk factors include loculated hydrocephalus (i.e., imaging evidence that the ventricles of the brain do not communicate with each other, in the setting of known communicating hydrocephalus); prior episodes of ventriculitis and/or shunt infection; subdural hematoma associated with shunt placement; inability to place a distal catheter in the peritoneal cavity due to scarring or prior infection; and multiple prior episodes of shunt failure.
- •In patients with communicating hydrocephalus who have significantly increased lateral and third ventricular size and normal fourth ventricular size, an endoscopic third ventriculostomy will be performed in conjunction with the choroid plexus cauterization, provided that communicating hydrocephalus is thought to be present, based on either the history (for example, past meningitis or other infectious or inflammatory disease, or history of communicating hydrocephalus without disproportion of the ventricles in the past; or imaging findings, such as patency of the foramina of Magendie and Luschka).
排除标准
- •Exclusion criteria include patients who have non-communicating hydrocephalus; patients who are undergoing emergency surgery because of rapid decline in neurologic condition; and patients with medical conditions such as coagulopathy or severe cardiac conditions, that preclude neurosurgical intervention.
- •In the case of adults unable to consent, informed consent will be obtained from appointed health care proxies. Minors, pregnant women, and prisoners will be excluded from the study.
研究组 & 干预措施
Choroid Plexus Coagulation
Patients with communicating hydrocephalus will be treated with endoscopic choroid plexus coagulation.
干预措施: endoscopic choroid plexus coagulation (Procedure)
结局指标
主要结局
Occurrence of post-operative complications
时间窗: 30 days
Complications will be defined as new neurologic deficits after surgery; hemorrhage or stroke on postoperative imaging studies; or other perioperative complications.
次要结局
- Shunt independence(1 year)
研究者
Ronald Benveniste
Associate Professor
University of Miami