The Impact of Endoscopic Pituitary Surgery on Nasal Function

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04018963
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zhebao Wu
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Zhebao Wu, phd
Principal Investigator Affiliation Ruijin Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pituitary Tumor, Endoscopic Surgery, Quality of Life, Function of Nose
Additional Details

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).

Arms & Interventions

Arms

: Uninostril group

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

: Binostril group

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

Interventions

Procedure: - Single nostril approach endoscopic transsphenoidal pituitary surgery

Single nostril approach endoscopic transsphenoidal pituitary surgery

Procedure: - Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Bilateral nostril approach endoscopic transsphenoidal pituitary surgery

Contact a Trial Team

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International Sites

Ruijin Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Ruijin Hospital

Shanghai, Shanghai, 200025

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