The Impact of Endoscopic Pituitary Surgery on Nasal Function

Quality of Life Clinical Trial

Official title:

Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04018963
• Other study ID #: NSPA-2019
• Status: Recruiting
• Start date: July 25, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2020
• Source: Ruijin Hospital
• Contact: Weiting Gu, Phd
• Phone: +86-021-64370045
• Email: nowaiting1221[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)．

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)．

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopic Surgery
• Function of Nose
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor
• Quality of Life

Intervention

Procedure:
• Single nostril approach endoscopic transsphenoidal pituitary surgery
Single nostril approach endoscopic transsphenoidal pituitary surgery
• Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Zhebao Wu	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal airway patency.	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.	Up to 3 months
Primary	Airflow patterns.	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal airflow patterns 3 months after surgery.	Up to 3 months
Primary	Temperature parameter.	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal temperature parameter 3 months after surgery.	Up to 3 months
Primary	Humidity parameter.	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal humidity parameter 3 months after surgery.	Up to 3 months
Primary	VAS	Record the Visual Analogue Scale(VAS) 3 months after surgery. The VAS scale includes six sub-scales: rhinorrhea VAS, rhinobyon VAS,rhinocnesmus VAS, cough VAS, sneezing VAS and olfaction VAS. Each scale has a maximum score of 10 and a minimum score of 0. The total VAS was the average of all sub-scales. Higher values represent a better outcome.	Up to 3 months
Primary	CT Lund-Mackay Score	Record the CT Lund-Mackay Score 3 months after surgery.The CT Lund-Mackay Score has a maximum score of 24 and a minimum score of 0. Higher values represent a worse outcome.	Up to 3 months
Primary	SNOT-20	Record the Sino-Nasal Outcome Record the Test-20(SNOT-20) 3 months after surgery. The SNOT-20 has a maximum score of 60 and a minimum score of 0. Higher values represent a worse outcome.	Up to 3 months
Primary	SF-36	Record the Medical Outcome Study Short Form 36-items Health survey(SF-36) 3 months after surgery. The SF-36 includes six sub-scales: General Health, Reported Health Transition,Physical Functioning, Role-Physical, Role-Emotional, Social Functioning, Bodily Pain, Vitality and Mental Health. Each scale has a maximum score of 100 and a minimum score of 0. The total score was the average of all sub-scales. Higher values represent a better outcome.	Up to 3 months
Secondary	Change on Tumor	Record the tumor volume from enhanced pituitary MRI 3 months after surgery.	Up to 3 months
Secondary	Nasal airway patency.	A bilateral model of the human nose on a CT-scan will be reconstructed to display geometric parameters of nasal cavity 1 week after surgery.	1 week after surgery
Secondary	Airflow patterns.	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal airflow patterns 1 week after surgery.	1 week after surgery
Secondary	Temperature parameter.	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal temperature parameter 1 week after surgery.	1 week after surgery
Secondary	Humidity parameter.	A bilateral model of the human nose on a CT-scan will be reconstructed. A numerical simulation applying the computational fluid dynamics (CFD) will be performed displaying intranasal humidity parameter 1 week after surgery.	1 week after surgery
Secondary	SF-36	Record the Medical Outcome Study Short Form 36-items Health survey(SF-36) 1 week after surgery. The SF-36 includes six sub-scales: General Health, Reported Health Transition,Physical Functioning, Role-Physical, Role-Emotional, Social Functioning, Bodily Pain, Vitality and Mental Health. Each scale has a maximum score of 100 and a minimum score of 0. The total score was the average of all sub-scales. Higher values represent a better outcome.	1 week after surgery
Secondary	SNOT-20	Record the Sino-Nasal Outcome Record the Test-20(SNOT-20) 1 week after surgery. The SNOT-20 has a maximum score of 60 and a minimum score of 0. Higher values represent a worse outcome.	1 week after surgery
Secondary	CT Lund-Mackay Score	Record the CT Lund-Mackay Score 1 week after surgery. The CT Lund-Mackay Score has a maximum score of 24 and a minimum score of 0. Higher values represent a worse outcome.	1 week after surgery
Secondary	VAS	Record the Visual Analogue Scale(VAS) 1 week after surgery. The VAS scale includes six sub-scales: rhinorrhea VAS, rhinobyon VAS,rhinocnesmus VAS, cough VAS, sneezing VAS and olfaction VAS. Each scale has a maximum score of 10 and a minimum score of 0. The total VAS was the average of all sub-scales. Higher values represent a better outcome.	1 week after surgery