Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: a Prospective Devleopment Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Technical feasibility
研究概览
简要总结
Pituitary adenoma can be difficult to cure with approximately a third of patients in contemporary series' undergoing incomplete resection. Over the last decade or so a handful of groups have described the use intraoperative ultrasound to improve resection. Although limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and effective technological adjunct to transsphenoidal surgery for pituitary adenoma.
In this prospective development study 30 adult patients will undergo transsphenoidal surgery for pituitary adenoma with prototype intraoperative ultrasound devices. The primary outcomes will be technical feasibility and device safety. The secondary outcomes will be complete versus incomplete radiological resection, endocrinological remission, the occurrence of postoperative complications, operating time, and length of stay.
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
- •undergoing transsphenoidal surgery
- •diagnosis of pituitary adenoma on pre-operative MRI
- •able to provide consent
排除标准
- •patients less than 18 years of age
- •patients undergoing transcranial surgery
- •diagnosis other than that of pituitary adenoma on pre-operative MRI e.g., meningioma
- •unable to provide consent e.g., mental illness or later withdrawing consent.
结局指标
主要结局
Technical feasibility
时间窗: Intraoperative
Technical feasibility will be assessed by the capacity of our system to provide ultrasound images of pituitary and adenoma tissue that correspond to pre- and post-operative MRI.
Device safety
时间窗: Intraoperative
Device safety will be assessed by the number, type, and severity of adverse events related to use of the device e.g., device malfunction.
次要结局
- Operating time (minutes)(Intra-operative)
- Length of stay (days)(Early post-operative)
- Radiological resection(Early post-operative)
- Endocrinological remission(Early post-operative)
- Postoperative complications(Early post-operative)