A Single-center, Prospective, Randomized Controlled Trial Investigating the Utility if Intraoperative MRI in Transphenoidal Pituitary Surgery Off Macroadenomas.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of gross total or maximal resection
研究概览
简要总结
The investigators are studying the utility of intra-operative magnetic resonance imaging (iMRI) during transsphenoidal pituitary surgery for large macroadenomas by randomizing patients to either an intra-operative MRI after resection, or no intra-operative MRI. The investigators will then count the number of gross total resection in each group of patients and also the complications related to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-90
- •Capable of giving informed consent
- •Elect for transsphenoidal surgery
- •Has pre-operative MRI demonstrating pituitary tumor that is:
- •deemed resectable using a transsphenoidal approach and
- •has a maximal diameter equal to or greater than 15 mm.
- •No contraindications for MRI.
排除标准
- •Children (age < 18)
- •Not able to give consent
- •No pituitary tumor visible on MRI or an adenoma measuring less than 15mm in maximal dimension.
- •Unable to tolerate MRI
研究组 & 干预措施
No intra-operative MRI
Patients undergo transsphenoidal surgery without an intra-operative MRI.
干预措施: Transsphenoidal resection of pituitary macroadenoma (Procedure)
intra-operative MRI
Patients undergo transspheonidal surgery followed by intra-operative MRI.
干预措施: intra-operative MRI (Other)
intra-operative MRI
Patients undergo transspheonidal surgery followed by intra-operative MRI.
干预措施: Transsphenoidal resection of pituitary macroadenoma (Procedure)
结局指标
主要结局
Rate of gross total or maximal resection
时间窗: 24 hours after surgery
Determine whether use of iMRI in transsphenoidal pituitary surgery for pituitary macroadenomas significantly increases the rate of maximal resection
次要结局
- Rate of Readmission(30 days post surgery)
- Length of anesthesia time(intraoperative)
- Rate of post-operative endocrinopathies(30 days post surgery)
- Frequency of post-operative CSF leak(30 days post surgery)
- Operative time(intraoperative)
研究者
Nathan E. Simmons
Staff Physician
Dartmouth-Hitchcock Medical Center