Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Change of QoL (Quality of Life, EQ-5D) for the second intervention
研究概览
简要总结
Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)
详细描述
There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 with Hypothalamic Involvement
- •Informed consent
排除标准
- •No follow-up possible
- •Emergency surgery without informed consent
结局指标
主要结局
Change of QoL (Quality of Life, EQ-5D) for the second intervention
时间窗: baseline (before the second intervention), 3 months after the second intervention
EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months
Change of QoL (Quality of Life, EQ-5D) for the first surgery
时间窗: baseline (before the first surgery), 2 years after the first surgery
EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years
次要结局
- Change of Hormone Replacement Therapy(baseline (before the first surgery), 2 years after the first surgery)
- Change of Visual Acuity statue(baseline (before the first surgery), 2 years after the first surgery)
- Extent of resection(baseline (before the first surgery), 2 years after the first surgery)
- Change of Visual Field statue(baseline (before the first surgery), 2 years after the first surgery)