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Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05448690
Enrollment
600
Registered
2022-07-07
Start date
2022-01-01
Completion date
2023-01-01
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Adenoma, Surgery

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.

Interventions

PROCEDURETwo different approaches

Please refer to Groups

PROCEDURENon-combined approach

Either transnasal, transcranial or a staged approach

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Extend of resectionOne month after surgeryhow much tumor was resected

Secondary

MeasureTime frameDescription
RisksOne month after surgeryProportion of Participants with hemorrage, infection or cranial nerve defect
Relapse or MortalityFrom date of surgery until the date of first documented date of death from any cause, assessed up to 3 months after surgeryDeath from any cause
Karnofsky performance scoreThree months after surgeryRanged from 0 to 100, the higher scores mean a better outcome

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026