Preoperative Octreotide Treatment of Patients With Growth Hormone Producing Pituitary Adenomas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- Surgical cure by transsphenoidal surgery
研究概览
简要总结
The purpose of this study is to investigate whether 6 months preoperative treatment with the somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.
详细描述
After a baseline evaluation, patients are randomized separately for each study center in blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with octreotide.
To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR (Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months. Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are delayed, an extra octreotide LAR injection is given before surgery.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GH nadir during a standard 75 g OGTT >= 5.0 mmol/L.
- •Pituitary tumor by MRI-scan.
排除标准
- •Immediate surgery indicated by usual clinical criteria.
- •Pregnant.
- •Known adverse effects of octreotide.
- •Unfit for participation by any other reason.
研究组 & 干预措施
octreotide
6 months preoperative treatment with octreotide before transsphenoidal surgery for acromegaly
干预措施: Octreotide (Drug)
standard surgery
Standard transphenoidal surgery soon after the diagnosis of acromegaly
干预措施: Direct surgery for acromegaly (Procedure)
结局指标
主要结局
Surgical cure by transsphenoidal surgery
时间窗: Primarily 3 months postoperatively, but up to 10 years postoperatively
次要结局
- Effect of treatment on surgical complications and duration of hospital stay, pituitary function, quality of life, and the need for postsurgical medical treatment of acromegaly(Primarily 3 months postoperatively, but up to 10 years postoperatively)