Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
1 other identifier
interventional
600
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable surgery
Started Jan 2022
Shorter than P25 for not_applicable surgery
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 2, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedOctober 29, 2024
October 1, 2024
1 year
July 2, 2022
October 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Extend of resection
how much tumor was resected
One month after surgery
Secondary Outcomes (3)
Risks
One month after surgery
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
Karnofsky performance score
Three months after surgery
Study Arms (2)
Non-combined approach (Single or Staged)
ACTIVE COMPARATORPatients underwent transnasal approach or craniotomy approach; Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery
Combined approach
EXPERIMENTALPatients underwent a combined approach using transnasal approach and craniotomy approach simultaneously
Interventions
Either transnasal, transcranial or a staged approach
Eligibility Criteria
You may qualify if:
- Giant pituitary adenoma (\> 4cm in diameter)
You may not qualify if:
- most of the tumor were in the sellae, sphenoidal sinus or clivus.
- patients with craniopharyngioma or meningioma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (13)
Chongqing People's Hospital
Chongqing, Chongqing Municipality, China
The first affliated hospital of Fujian Medical Hospital
Fuzhou, Fujian, 350005, 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, 20000, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 20000, China
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, 20000, 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
Related Publications (1)
Qiao N, Gao W, Deng X, Xin T, Zhang G, Wu N, Wang P, Bi Y, Cong Z, Zhou Z, Li J, Sun S, Li M, Tang W, Yan X, Wang W, Qiu W, Yao S, Ye Z, Ma Z, Zhou X, Cao X, Shen M, Shou X, Zhang Z, Wu Z, Chu L, Qiu Y, Ma H, Wu A, Ma C, Lou M, Jiang C, Wang Y, Zhao Y. Combined simultaneous transsphenoidal and transcranial regimen improves surgical outcomes in complex giant pituitary adenomas: a longitudinal retrospective cohort study. Int J Surg. 2024 Jul 1;110(7):4043-4052. doi: 10.1097/JS9.0000000000001330.
PMID: 38498406DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
July 2, 2022
First Posted
July 7, 2022
Study Start
January 1, 2022
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
October 29, 2024
Record last verified: 2024-10