- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018963
The Impact of Endoscopic Pituitary Surgery on Nasal Function
October 7, 2020 updated by: Zhebao Wu
Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery.
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).
Study Overview
Status
Unknown
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).
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weiting Gu, Phd
- Phone Number: +86-021-64370045
- Email: nowaiting1221@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital
-
Contact:
- Weiting Gu
- Phone Number: +8602164370045 +8602164370045
- Email: nowaiting1221@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated with endoscopic surgery
Description
Inclusion Criteria:
- Enhanced MRI shows a pituitary tumor
- Endoscopic surgery is required according to the pituitary tumor treatment guidelines.
- Karnofsky performance status ≥ 70.
- The patient has signed the informed consent.
Exclusion Criteria:
- Patients who have undergone previous transsphenoidal surgery or other nasal surgery.
- Patients who had a history of nasal tumors.
- Patients who had a history of severe head or face trauma.
- Patients with congenital sinus malformation.
- Pregnant or lactating women.
- Patients with serious systemic diseases without control.
- Patients with poor compliance, who cannot implement the program strictly.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Uninostril group
Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the single nostril approach.
|
Single nostril approach endoscopic transsphenoidal pituitary surgery
|
Binostril group
Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the bilateral nostril approach.
|
Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nasal airway patency.
Time Frame: Up to 3 months
|
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
|
Airflow patterns.
Time Frame: Up to 3 months
|
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
|
Temperature parameter.
Time Frame: Up to 3 months
|
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
|
Humidity parameter.
Time Frame: Up to 3 months
|
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
|
VAS
Time Frame: Up to 3 months
|
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
|
CT Lund-Mackay Score
Time Frame: Up to 3 months
|
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
|
SNOT-20
Time Frame: Up to 3 months
|
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
|
SF-36
Time Frame: Up to 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on Tumor
Time Frame: Up to 3 months
|
Record the tumor volume from enhanced pituitary MRI 3 months after surgery.
|
Up to 3 months
|
Nasal airway patency.
Time Frame: 1 week after surgery
|
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
|
Airflow patterns.
Time Frame: 1 week after surgery
|
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
|
Temperature parameter.
Time Frame: 1 week after surgery
|
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
|
Humidity parameter.
Time Frame: 1 week after surgery
|
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
|
SF-36
Time Frame: 1 week after surgery
|
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
|
SNOT-20
Time Frame: 1 week after surgery
|
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
|
CT Lund-Mackay Score
Time Frame: 1 week after surgery
|
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
|
VAS
Time Frame: 1 week after surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zhebao Wu, phd, Ruijin Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2019
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
July 10, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 15, 2019
Study Record Updates
Last Update Posted (Actual)
October 9, 2020
Last Update Submitted That Met QC Criteria
October 7, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Pituitary Neoplasms
- Pituitary Diseases
Other Study ID Numbers
- NSPA-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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