Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
- Conditions
- SurgeryPituitary Adenoma
- Interventions
- Procedure: Two different approaches
- Registration Number
- NCT05448690
- Lead Sponsor
- Huashan Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- Giant pituitary adenoma (> 4cm in diameter)
- most of the tumor were in the sellae, sphenoidal sinus or clivus.
- patients with craniopharyngioma or meningioma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined approach Two different approaches Patients underwent a combined approach using transnasal approach and craniotomy approach simultaneously
- Primary Outcome Measures
Name Time Method Extend of resection One month after surgery how much tumor was resected
- Secondary Outcome Measures
Name Time Method 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 Death from any cause
Karnofsky performance score Three months after surgery Ranged from 0 to 100, the higher scores mean a better outcome
Risks One month after surgery Proportion of Participants with hemorrage, infection or cranial nerve defect
Trial Locations
- Locations (13)
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, 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 China Medical University
🇨🇳Shenyang, Jilin, China
General hospital of Eastern Theater Command
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Huashan Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Renji Hospital
🇨🇳Shanghai, Shanghai, China
Changzhi People's Hospital
🇨🇳Changzhi, Shanxi, China
The first hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The first affliated hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China