Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 13
- 主要终点
- Extend of resection
研究概览
简要总结
The surgical treatment strategy for giant invasive pituitary adenoma is one of the current hot spots in the field of clinical research on pituitary adenoma. A comprehensive literature search resulted in numerous previous studies to investigate the efficacy, advantages and disadvantages of different surgical options.
A single approach (transnasal or craniotomy) is theoretically less invasive and has a shorter hospital stay for the patient, but may result in postoperative bleeding due to residual tumor and damage to the intracranial vessels adhering to the tumor.
The advantage of the combined approach is that the tumor can be removed to the greatest extent possible. In addition, postoperative suprasellar hemorrhage can be prevented by careful hemostasis or intracranial drainage by the transcranial team if necessary. In this way, the risk of postoperative bleeding due to residual tumor can be significantly reduced.
In some cases, waiting a few months after the initial surgery for a second-stage procedure may also be an option when the patient's condition does not allow for a combined access procedure, when the tumor is hard, or when the blood preparation is insufficient. However, staged surgery increases the financial burden on the patient, and local scar formation may make second-stage surgery more difficult and decrease the likelihood of endocrine remission of functional pituitary tumors.
Given the complexity of the treatment of giant invasive pituitary adenoma, there is a need to conduct studies comparing the combined transnasal cranial approach, the single access transnasal or cranial approach, and the staged approach simultaneously to assess whether the combined transnasal cranial approach is superior to the single access transnasal or cranial approach or the staged approach in improving the tumor resection rate in giant invasive pituitary adenoma.
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
- None
入排标准
- 年龄范围
- 6 Years 至 85 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Giant pituitary adenoma (> 4cm in diameter)
排除标准
- •most of the tumor were in the sellae, sphenoidal sinus or clivus.
- •patients with craniopharyngioma or meningioma.
研究组 & 干预措施
Combined approach
Patients underwent a combined approach using transnasal approach and craniotomy approach simultaneously
干预措施: Two different approaches (Procedure)
Non-combined approach (Single or Staged)
Patients underwent transnasal approach or craniotomy approach; Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery
干预措施: Non-combined approach (Procedure)
结局指标
主要结局
Extend of resection
时间窗: One month after surgery
how much tumor was resected
次要结局
- Risks(One month after surgery)
- Relapse or Mortality(From date of surgery until the date of first documented date of death from any cause, assessed up to 3 months after surgery)
- Karnofsky performance score(Three months after surgery)
