NCT06679816招募中4 期
Study on the Efficacy of Hydrocortisone in Perioperative Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors:a Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled Study
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 882 人开始时间: 2024年12月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 882
- 试验地点
- 1
- 主要终点
- The incidence of adrenal insufficiency on the first or second day after surgery
研究概览
简要总结
The goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. The main questions it aims to answer are:
• Does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants? Researchers will compare hydrocortisone to a placebo (a look-alike substance that contains no drug) to see if hydrocortisone works to reduce the incidence of adrenal insufficiency.
Participants will:
- Take or intravenous infusion drug hydrocortisone or a placebo every day for 2 weeks
- Visit the clinic three months after surgery for checkups and tests
- Keep a diary of their symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age range: 18-70 years old;
- •(2) Accept PitNETs patients who can be treated with endoscopic transsphenoidal surgery;
- •(3) The maximum diameter of the tumor is ≥ 2 centimeters;
- •(4) Preoperative hypothalamic pituitary adrenal axis integrity;
- •(5) The subject or their legal representative signs the informed consent form
排除标准
- •(1) Patients with a history of Cushing's disease or adrenal insufficiency;
- •(2) Emergency and combined hormone therapy patients;
- •(3) Pituitary stroke patients;
- •(4) Patients lacking head magnetic resonance imaging;
研究组 & 干预措施
Hormone supplementation therapy group
Experimental
干预措施: Hormone replacement therapy (Drug)
Placebo therapy group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of adrenal insufficiency on the first or second day after surgery
时间窗: the first or second day after surgery
次要结局
- The incidence of adrenal insufficiency within 90 days after surgery(Within 90 days after surgery)
研究者
研究点 (1)
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