The Impact of Endoscopic Pituitary Surgery on Nasal Function

NCT ID: NCT04018963

Last Updated: 2020-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-25

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Pituitary Tumor Endoscopic Surgery Quality of Life Function of Nose

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Uninostril group

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

Single nostril approach endoscopic transsphenoidal pituitary surgery

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Interventions

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Single nostril approach endoscopic transsphenoidal pituitary surgery

Single nostril approach endoscopic transsphenoidal pituitary surgery

Intervention Type PROCEDURE

Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Zhebao Wu

OTHER

Sponsor Role lead

Responsible Party

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Zhebao Wu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhebao Wu, phd

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weiting Gu, Phd

Role: CONTACT

+86-021-64370045

Facility Contacts

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Weiting Gu

Role: primary

+8602164370045 ext. +8602164370045

References

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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.

Reference Type BACKGROUND
PMID: 25839931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30683122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26047408 (View on PubMed)

Other Identifiers

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NSPA-2019

Identifier Type: -

Identifier Source: org_study_id

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