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临床试验/NCT05448690
NCT05448690已完成不适用

Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

Huashan Hospital13 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

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

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

Experimental

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)

Active Comparator

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoyun Zhang

Prof

Huashan Hospital

研究点 (13)

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