Compare Between Endoscopic and Microsurgical Transsphenoidal Resection of Pituitary Adenomas With Intraoperative MRI
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- endocrine function
研究概览
简要总结
Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.
详细描述
The main aim of the study is to compare microsurgical and endoscopic transsphenoidal surgery and to determine endocrine outcome. Secondary extent of resection and quality of life will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
only surgeon knows the used technique, endocrinologist, patient and all involved medical staff is blinded
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
- •Suspected symptomatic or progressively growing pituitary adenoma
- •Informed consent
排除标准
- •Prolactinoma
- •No follow-up possible
- •Emergency surgery without informed consent or without intraoperative MRI
结局指标
主要结局
endocrine function
时间窗: 1 year after surgery
Testing of pituitary function with insulin-hypoglycemic test, results will be dichotomized as satisfactory or not satisfactory. Satisfactory outcome is defined, if pituitary function improves or is stable, if compared to preoperative testing.
次要结局
- Extent of resection(tumor volume before the surgery, 3 months after surgery)
- Quality of Life, EQ-5D(3 months and 1 year after surgery)
研究者
Andrej Pala
Principal Investigator
University of Ulm