The Impact of Endoscopic Pituitary Surgery on Nasal Function

NCT04018963 | Unknown DMC

• 1 other identifier: NSPA-2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)．

Conditions

Pituitary Tumor; Endoscopic Surgery; Quality of Life; Function of Nose

Keywords

Pituitary tumor; Neuroendoscope; Surgical approach; Computational Fluid Dynamics; Numerical simulation

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• Change on Tumor

  Up to 3 months

• Nasal airway patency.

  1 week after surgery

• Airflow patterns.

  1 week after surgery

• Temperature parameter.

  1 week after surgery

• Humidity parameter.

  1 week after surgery

Study Arms (2)

Uninostril group

Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the single nostril approach.

Procedure: Single nostril approach endoscopic transsphenoidal pituitary surgery

Binostril group

Subjects will be treated with endoscopic transsphenoidal pituitary surgery with the bilateral nostril approach.

Procedure: Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Interventions

Single nostril approach endoscopic transsphenoidal pituitary surgery PROCEDURE

Single nostril approach endoscopic transsphenoidal pituitary surgery

Uninostril group

Bilateral nostril approach endoscopic transsphenoidal pituitary surgery PROCEDURE

Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Binostril group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with endoscopic surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhebao Wu: lead
• Shanghai Zhongshan Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related 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.

  PMID: 25839931 BACKGROUND

• 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.

  PMID: 30683122 BACKGROUND

• 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.

  PMID: 26047408 BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Zhebao Wu, phd

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiting Gu, Phd

CONTACT

+86-021-64370045; nowaiting1221@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: July 25, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

CN (1)