Clinical trial NCT04018963: The Impact of Endoscopic Pituitary Surgery on Nasal Function
Official title: Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Tumor
Endoscopic Surgery
Quality of Life
Function of Nose
Keywords: Pituitary tumor
Neuroendoscope
Surgical approach
Computational Fluid Dynamics
Numerical simulation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: The First Affiliated Hospital of Nanchang University
First posted: 2019-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with endoscopic surgery

Brief summary: 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)．

Detailed description: Neuroendoscopic surgery is the first treatment for most pituitary adenoma patients. Because transsphenoidal surgery exploits the nasal corridor and paranasal sinuses to reach the skull base, sinonasal trauma is a primary source of postoperative morbidity in many of these patients. 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)．

Eligibility criteria: 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.

Primary outcomes:
measure: Nasal airway patency.
timeFrame: Up to 3 months
measure: Airflow patterns.
timeFrame: Up to 3 months
measure: Temperature parameter.
timeFrame: Up to 3 months
measure: Humidity parameter.
timeFrame: Up to 3 months
measure: VAS
timeFrame: Up to 3 months
measure: CT Lund-Mackay Score
timeFrame: Up to 3 months
measure: SNOT-20
timeFrame: Up to 3 months
measure: SF-36
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change on Tumor
timeFrame: Up to 3 months
measure: Nasal airway patency.
timeFrame: 1 week after surgery
measure: Airflow patterns.
timeFrame: 1 week after surgery
measure: Temperature parameter.
timeFrame: 1 week after surgery
measure: Humidity parameter.
timeFrame: 1 week after surgery
measure: SF-36
timeFrame: 1 week after surgery
measure: SNOT-20
timeFrame: 1 week after surgery
measure: CT Lund-Mackay Score
timeFrame: 1 week after surgery
measure: VAS
timeFrame: 1 week after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Zhebao Wu, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Little 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.
citation: Tian 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.
citation: McCoul 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.