Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- pituitary hormone levels
研究概览
简要总结
The investigators carried out a multi-center comparative study, involving hospitals including the Second Affiliated Hospital of Zhejiang University School of Medicine, Peking Union Medical College Hospital, West China Hospital, Wenzhou First Hospital, and Li Huili Hospital. This study aimed to compare the efficacy of medication and surgery for specific subtypes of microadenomas and clearly defined macroadenomas (Knosp grades 0-2), in order to determine which is more effective and which has fewer benefits, thereby enhancing the evidence base.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prolactin level greater than three times the normal upper limit
- •MRI indicates Knosp Grade 0-2 pituitary adenoma
排除标准
- •MRI indicates Knosp grade 3-4 pituitary adenoma
- •Taking antidepressants or other psychotropic drugs
- •Patients allergic to bromocriptine or cannot tolerate surgery
- •Women defined as surgical infertility (i.e. hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or amenorrhea for more than 2 years
- •Critical illness patients, such as those with progressive consciousness disorders, cerebral hernias, and other emergency situations
研究组 & 干预措施
Operation group
Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy
干预措施: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy (Procedure)
Drug group
Bromocriptin 2.5mg, 2-3 times a day
干预措施: Bromocriptin 2.5mg, 2-3 times a day (Drug)
结局指标
主要结局
pituitary hormone levels
时间窗: At 1, 3, 6, 9 and 12 months postoperatively
Recheck pituitary hormones (PRL, GH, ACTH, etc.)
pituitary MRI
时间窗: At 1,6 and 12 months postoperatively
Recheck pituitary MRI
次要结局
- sexual function evaluation(At 1,6 and 12 months postoperatively)
- menstrual condition(At 6 and 12 months postoperatively)
- lactation(At 1,6 and 12 months postoperatively)