A Prospective, Randomized Trial of Preoperative Lanreotide Treatment in Acromegalic Patients With Macroadenomas
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Cure rate at evaluation 4 months postoperatively
研究概览
简要总结
Previous studies addressing preoperative somatostatin analogs (SSA) treatment and subsequent surgical cure rates are conflicting, reporting a benefit, or no difference between groups. And most reported studies were rather small and were made in retrospect, we conducted a prospective, randomized study to investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. The investigators also aimed to investigate whether there were differences in the incidence of surgical complications, and duration of neurosurgical hospital stay.
详细描述
Acromegaly is a rare disease, caused by a growth hormone (GH)-secreting adenoma and in even more seldom instances (about 1%) due to excessive growth hormone-releasing hormone (GHRH) secretion, usually by a carcinoid tumor of the lung or gastrointestinal tract. The incidence of acromegaly is about 3-4 per 1 million per year and the prevalence is 60-70 per 1 million, without geographical or sex differences. Clinical features of acromegaly include acral enlargement, prognathism, jaw malocclusion, arthropathy, carpal tunnel syndrome, hyperhydrosis, sleep apnea, and visceromegaly.
Transsphenoidal neurosurgery, allowing selective removal of the pituitary adenoma, is the current first treatment for acromegaly in the majority of patients. Its effects on GH and insulin-like growth factor I (IGF-I) secretion are rapid and operations have a low morbidity and very low mortality. However, surgery for macroadenomas causing acromegaly has a much lower surgical success rate than that for microadenomas. In experienced hands, microadenomas can be expected to be cured in around 90%, whereas with macroadenomas the figure is around 50%. This is particularly the case with tumours that extend into the cavernous sinus where surgical success is < 50%. Medical treatment of acromegaly with somatostatin analogs (SSAs) can lead to normalized GH and IGF-I levels and relief of symptoms. SSA treatment may cause shrinkage of GH-secreting pituitary adenomas. Theoretically, this could improve the likelihood of a radical resection, particularly in macroadenomas. Furthermore, it has been suggested that SSA treatment softens the tumor parenchyma and thereby facilitates tumor removal. Finally, it has been reported that SSA pretreatment leads to a shortening of postoperative hospital stay.
Previous studies addressing preoperative SSA treatment and subsequent surgical cure rates are conflicting, reporting a benefit, or no difference between groups. And most reported studies were rather small and were made in retrospect, we conducted a prospective, randomized study to investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. We also aimed to investigate whether there were differences in the incidence of surgical complications, and duration of neurosurgical hospital stay.
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
- •patients with newly diagnosed acromegaly due to GH-secreting macro-adenomas.
- •newly diagnosed, previously untreated patients with GH nadir more than 2.5 μg/L during a standard 75-g, 2-h oral glucose tolerance test (OGTT)
- •pituitary macroadenomas (maximum diameter >1 cm) verified by a pituitary magnetic resonance imaging (MRI) scan
- •age between 18 and 80 yr.
排除标准
- •immediate surgery indicated by clinical criteria
- •pregnancy
- •contraindications to MRI scan
- •patients judged not suitable to participate in the study for other reasons such as personality disorders and alcohol abuse.
研究组 & 干预措施
Group 2
After a baseline evaluation, patients underwent transsphenoidal surgery (direct surgery group).
干预措施: Transsphenoidal surgery (Procedure)
Group 1
Patients received lanreotide for 16 weeks before the surgical resection [starting with 30 mg/2 weeks i.m. and increasing to 30 mg/week i.m. at week 8, if mean GH > 5 mU/L on GH day curve (GHDC)] (GHDC: 9×30-min samples collected in the morning after an overnight fast and rest, through an indwelling catheter inserted in an arm vein and while the patient was resting).
干预措施: Preoperative lanreotide treatment (Drug)
结局指标
主要结局
Cure rate at evaluation 4 months postoperatively
时间窗: every 4 weeks
次要结局
- Postoperative hospital stay duration(every 4 weeks)
