NCT05448690

Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Surgery
• Pituitary Adenoma

Interventions

Type	Name	Description
PROCEDURE	Two different approaches	Please refer to Groups
PROCEDURE	Non-combined approach	Either transnasal, transcranial or a staged approach

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2022-07-07
• Last updated: 2024-10-29

Locations

13 sites across 1 country: China