Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

Surgery Clinical Trial

Official title:

Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448690
• Other study ID #: KY2022-060
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2022
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 85 Years

Eligibility

Inclusion Criteria:

• Giant pituitary adenoma (> 4cm in diameter)

Exclusion Criteria:

• most of the tumor were in the sellae, sphenoidal sinus or clivus.

• patients with craniopharyngioma or meningioma.

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Surgery

Intervention

Procedure:
• Two different approaches
Please refer to Groups

Locations

Country	Name	City	State
China	Changzhi People's Hospital	Changzhi	Shanxi
China	Chongqing People's Hospital	Chongqing	Chongqing
China	The first affliated hospital of Fujian Medical Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong
China	The first affliated hospital of Kunming Medical University	Kunming	Yunnan
China	General hospital of Eastern Theater Command	Nanjing	Jiangsu
China	Huashan Hospital	Shanghai	Shanghai
China	Shanghai General Hospital	Shanghai	Shanghai
China	Shanghai Renji Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of China Medical University	Shenyang	Jilin
China	The first hospital of Shanxi Medical University	Taiyuan	Shanxi
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extend of resection	how much tumor was resected	One month after surgery
Secondary	Risks	Proportion of Participants with hemorrage, infection or cranial nerve defect	One month after surgery
Secondary	Relapse or Mortality	Death from any cause	From date of surgery until the date of first documented date of death from any cause, assessed up to 3 months after surgery
Secondary	Karnofsky performance score	Ranged from 0 to 100, the higher scores mean a better outcome	Three months after surgery