Clinical trial NCT05448690: Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
Official title: Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Pituitary Adenoma
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Extend of resection
timeFrame: One month after surgery
Secondary outcomes:
measure: Risks
timeFrame: One month after surgery
measure: Relapse or Mortality
timeFrame: From date of surgery until the date of first documented date of death from any cause, assessed up to 3 months after surgery
measure: Karnofsky performance score
timeFrame: Three months after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing People's Hospital
state: Chongqing
city: Fuzhou
country: China
facility: The first affliated hospital of Fujian Medical Hospital
state: Fujian
city: Guiyang
country: China
facility: The First Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Nanjing
country: China
facility: General hospital of Eastern Theater Command
state: Jiangsu
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Renji Hospital
state: Shanghai
city: Changzhi
country: China
facility: Changzhi People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: The first hospital of Shanxi Medical University
state: Shanxi
city: Kunming
country: China
facility: The first affliated hospital of Kunming Medical University
state: Yunnan
Study officials:
References: