Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
NCT ID: NCT05448690
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
2022-01-01
2023-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-combined approach (Single or Staged)
Patients underwent transnasal approach or craniotomy approach; Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery
Non-combined approach
Either transnasal, transcranial or a staged approach
Combined approach
Patients underwent a combined approach using transnasal approach and craniotomy approach simultaneously
Two different approaches
Please refer to Groups
Interventions
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Two different approaches
Please refer to Groups
Non-combined approach
Either transnasal, transcranial or a staged approach
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients with craniopharyngioma or meningioma.
6 Years
85 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Zhaoyun Zhang
Prof
Locations
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Chongqing People's Hospital
Chongqing, Chongqing Municipality, China
The first affliated hospital of Fujian Medical Hospital
Fuzhou, Fujian, 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, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, 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
Countries
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References
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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.
Other Identifiers
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KY2022-060
Identifier Type: -
Identifier Source: org_study_id
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