Clinical trial · Observational
The Impact of Endoscopic Pituitary Surgery on Nasal Function
Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery.
NCT04018963CI-TRIAL-00047606unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 aim of this study is to determine the impact of endoscopic transsphenoidal pituitary surgery on nasal function using a numerical simulation and to compare the difference between two kinds of transsphenoidal approachese(single nostril approach and bilateral nostril approach)．
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endoscopic Surgery | — | UNRESOLVED | — |
| Function of Nose | — | UNRESOLVED | — |
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bilateral nostril approach endoscopic transsphenoidal pituitary surgery | Procedure | — | UNRESOLVED |
| Single nostril approach endoscopic transsphenoidal pituitary surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Uninostril group
- description
- Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the single nostril approach.
- interventionNames
- Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgery
- label
- Binostril group
- description
- Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the bilateral nostril approach.
- interventionNames
- Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
Primary outcomes (8)
- measure
- Nasal airway patency.
- timeFrame
- Up to 3 months
- description
- A bilateral model of the human nose on a CT-scan will be reconstructed to display geometric parameters of nasal cavity 3 months after surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Enhanced MRI shows a pituitary tumor 2. Endoscopic surgery is required according to the pituitary tumor treatment guidelines. 3. Karnofsky performance status ≥ 70. 4. The patient has signed the informed consent. Exclusion Criteria: 1. Patients who have undergone previous transsphenoidal surgery or other nasal surgery. 2. Patients who had a history of nasal tumors. 3. Patients who had a history of severe head or face trauma. 4. Patients with congenital sinus malformation. 5. Pregnant or lactating women. 6. Patients with serious systemic diseases without control. 7. Patients with poor compliance, who cannot implement the program strictly.
References
Publications (3)
- BACKGROUNDLittle AS, Kelly D, Milligan J, Griffiths C, Prevedello DM, Carrau RL, Rosseau G, Barkhoudarian G, Otto BA, Jahnke H, Chaloner C, Jelinek KL, Chapple K, White WL. Predictors of sinonasal quality of life and nasal morbidity after fully endoscopic transsphenoidal surgery. J Neurosurg. 2015 Jun;122(6):1458-65. doi: 10.3171/2014.10.JNS141624. Epub 2015 Apr 3. PMID 25839931
- BACKGROUNDTian L, Shang Y, Chen R, Bai R, Chen C, Inthavong K, Tu J. Correlation of regional deposition dosage for inhaled nanoparticles in human and rat olfactory. Part Fibre Toxicol. 2019 Jan 25;16(1):6. doi: 10.1186/s12989-019-0290-8. PMID 30683122
- BACKGROUNDMcCoul ED, Bedrosian JC, Akselrod O, Anand VK, Schwartz TH. Preservation of multidimensional quality of life after endoscopic pituitary adenoma resection. J Neurosurg. 2015 Sep;123(3):813-20. doi: 10.3171/2014.11.JNS14559. Epub 2015 Jun 5. PMID 26047408