Pituitary TumorNCT04018963

The Impact of Endoscopic Pituitary Surgery on Nasal Function

An observational study of Pituitary Tumor and Endoscopic Surgery, run by Zhebao Wu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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)． Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Pituitary Tumor, Endoscopic Surgery, Quality of Life
What is being tested?: Single nostril approach endoscopic transsphenoidal pituitary surgery and Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
Type of treatment: Surgery or procedure
How many people: 100 participants
Where: 1 siteChina
Study dates: 25 Jul 2019to 31 Dec 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients treated with endoscopic surgery

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Weiting Gu, Phd contact

+86-021-64370045

nowaiting1221@hotmail.com

China1 site, 1 recruiting

Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Weiting Gu, +8602164370045 ext. +8602164370045, nowaiting1221@hotmail.com
Recruiting

Other trials in China

About this study

Official title: Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery.

Read the 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)．

Conditions: Pituitary Tumor, Endoscopic Surgery, Quality of Life, Function of Nose
Being tested: Single nostril approach endoscopic transsphenoidal pituitary surgery, Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
Keywords: Pituitary tumor, Neuroendoscope, Surgical approach, Computational Fluid Dynamics, Numerical simulation
Medical subject headings: Pituitary Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Single nostril approach endoscopic transsphenoidal pituitary surgeryProcedure or surgery
Single nostril approach endoscopic transsphenoidal pituitary surgery
Bilateral nostril approach endoscopic transsphenoidal pituitary surgeryProcedure or surgery
Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Study groups in NCT04018963
Study group	Role	What they receive
Uninostril group		Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the single nostril approach. Receives: Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgery
Binostril group		Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the bilateral nostril approach. Receives: Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 3 months
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.
Measured: Up to 3 months
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.
Measured: Up to 3 months
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.
Measured: Up to 3 months
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.
Measured: Up to 3 months
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.
Measured: Up to 3 months
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.
Measured: Up to 3 months
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.
Measured: Up to 3 months

Secondary outcomes (9)

Change on Tumor
Record the tumor volume from enhanced pituitary MRI 3 months after surgery.
Measured: Up to 3 months
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.
Measured: 1 week after surgery
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.
Measured: 1 week after surgery
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.
Measured: 1 week after surgery
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.
Measured: 1 week after surgery
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.
Measured: 1 week after surgery
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.
Measured: 1 week after surgery
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.
Measured: 1 week after surgery
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.
Measured: 1 week after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 201931 Dec 2021

First posted15 Jul 2019
Study start25 Jul 2019
Primary completion31 Dec 2021 (estimated)
Study completion31 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pituitary TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04018963
Sponsor's protocol ID: NSPA-2019
Status last verified: Oct 2020
First submitted: 10 Jul 2019
Last updated: 9 Oct 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 25839931
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.
PubMed 30683122
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.
PubMed 26047408

Want to know more?

Weiting Gu, Phd

+86-021-64370045

nowaiting1221@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pituitary Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Numerical Simulation Analysis of Nasal Physiology After Endoscopic Pituitary Surgery.
ClinicalTrials.gov ID: NCT04018963
Acronym / sponsor ID: NSPA-2019
Conditions: Pituitary Tumor, Endoscopic Surgery, Quality of Life, Function of Nose
Keywords: Pituitary tumor, Neuroendoscope, Surgical approach, Computational Fluid Dynamics, Numerical simulation
Study type: Observational
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Zhebao WuUniversity, hospital or other
Collaborators: Shanghai Zhongshan Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Nanchang University
Study start: 25 Jul 2019 (actual)
Primary completion: 31 Dec 2021 (estimated)
Study completion: 31 Dec 2021 (estimated)
First posted: 15 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Uninostril group	–	Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgerySubjects will be treated with endoscopic transsphenoidal pituitary surgery with the single nostril approach.
Binostril group	–	Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgerySubjects will be treated with endoscopic transsphenoidal pituitary surgery with the bilateral nostril approach.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients treated with endoscopic surgery

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Single nostril approach endoscopic transsphenoidal pituitary surgerySingle nostril approach endoscopic transsphenoidal pituitary surgery	Procedure or surgery	Uninostril group
Bilateral nostril approach endoscopic transsphenoidal pituitary surgeryBilateral nostril approach endoscopic transsphenoidal pituitary surgery	Procedure or surgery	Binostril group

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.

9 secondary outcomes

Change on Tumor
Time frame: Up to 3 months
Nasal airway patency.
Time frame: 1 week after surgery
Airflow patterns.
Time frame: 1 week after surgery
Temperature parameter.
Time frame: 1 week after surgery
Humidity parameter.
Time frame: 1 week after surgery
SF-36
Time frame: 1 week after surgery
SNOT-20
Time frame: 1 week after surgery
CT Lund-Mackay Score
Time frame: 1 week after surgery
VAS
Time frame: 1 week after surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
Background: PubMed 25839931Little 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.
Background: PubMed 30683122Tian 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.
Background: PubMed 26047408McCoul 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Weiting Gu, Phd contact

+86-021-64370045

nowaiting1221@hotmail.com

Zhebao Wu, phd principal investigator

Ruijin Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pituitary Tumor and Endoscopic Surgery, run by Zhebao Wu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weiting Gu, Phd (+86-021-64370045, nowaiting1221@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nasal airway patency. (time frame: Up to 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04018963, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.