Clinical trial · Interventional
Comparative Effectiveness of Different Surgical Approaches for Giant Pituitary Adenomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-combined approach | Procedure | — | UNRESOLVED |
| Two different approaches | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Non-combined approach (Single or Staged)
- description
- Patients underwent transnasal approach or craniotomy approach; Patients underwent an initial surgery and a sencond staged surgery several months after the initial surgery
- interventionNames
- Procedure: Non-combined approach
- type
- EXPERIMENTAL
- label
- Combined approach
- description
- Patients underwent a combined approach using transnasal approach and craniotomy approach simultaneously
- interventionNames
- Procedure: Two different approaches
Primary outcomes (1)
- measure
- Extend of resection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDQiao 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 38498406