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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Please refer to Groups
Either transnasal, transcranial or a staged approach
Chongqing People's Hospital
Chongqing, Chongqing Municipality, China
The first affliated hospital of Fujian Medical Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
General hospital of Eastern Theater Command
Nanjing, Jiangsu, China
The First Affiliated Hospital of China Medical University
Shenyang, Jilin, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
...and 3 more locations
Extend of resection
how much tumor was resected
Time frame: One month after surgery
Risks
Proportion of Participants with hemorrage, infection or cranial nerve defect
Time frame: One month after surgery
Relapse or Mortality
Death from any cause
Time frame: 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
Ranged from 0 to 100, the higher scores mean a better outcome
Time frame: Three months after surgery
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