Pituitary TumorNCT04938401
Construction and Application of a Risk Prediction Model Forepistaxis After Pituitary Tumor Resection
An observational study of Pituitary Tumor, run by Wang Ying supervisor nurse.
Trial summary
(1) Objective to establish an evaluation system for predicting the risk of epistaxis after endoscopic transsphenoidal pituitary surgery（ 2) Objective to determine the risk factors of epistaxis after endoscopic transsphenoidal pituitary adenoma surgery. Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Pituitary Tumor
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2021to 31 Dec 2023
- How long will I take part?
- 2 Years
- 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 14 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Patients after transnasal sphenoidal resection of pituitary tumor
Who may be able to join
- Those who met the diagnostic criteria of pituitary tumor and received transsphenoidal endoscopic surgery during hospitalization; Patients with informed consent; Age ≥ 14 years old.
Who cannot join
- quitters; patients with incomplete clinical data;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Construction and Application of a Risk Prediction Model Forepistaxis After Endoscopic Transsphenoidal Pituitary Tumor Resection
(1) Objective to establish an evaluation system for predicting the risk of epistaxis after endoscopic transsphenoidal pituitary surgery（ 2) Objective to determine the risk factors of epistaxis after endoscopic transsphenoidal pituitary adenoma surgery. Referring to domestic and foreign literature, combined with experts' opinions, the related risk factors that may cause postoperative nosebleed of pituitary adenoma are: 22 patients and surgical factors. 3) Objective to establish a risk prediction model of epistaxis after endoscopic transsphenoidal pituitary tumor resection. According to the occurrence of epistaxis, the patients in the modeling group were divided into epistaxis group and non epistaxis group. The risk factors of epistaxis were taken as the independent variable, and the occurrence of epistaxis was taken as the dependent variable. The variables with statistical significance in univariate analysis were included in the multivariate logistic regression model, and the risk prediction model of epistaxis after pituitary tumor resection was established by back LR method.(4) Objective to verify the risk prediction model of endoscopic transsphenoidal pituitary adenoma epistaxis. The validation model is used to validate the prediction model, and the Hosmer-Lemeshow degree is used to match the model. The area under the receiver operating characteristic curve (ROC) was used to evaluate the validity of the model.(5) Application of risk prediction model.
- Conditions
- Pituitary Tumor
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| epistaxis | Postoperative pituitary tumor group with epistaxis | |
| no epistaxis | Postoperative pituitary tumor group without epistaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of epistaxis
Overall incidence of epistaxis
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start2 Jul 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Wang Ying supervisor nurse
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Zhejiang University, Zhejiang Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Wang Ying supervisor nurse, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- YIing Wang, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938401
- Sponsor's protocol ID
- Neurosurgery 5 Ward
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of a Risk Prediction Model Forepistaxis After Endoscopic Transsphenoidal Pituitary Tumor Resection
- ClinicalTrials.gov ID
- NCT04938401
- Acronym / sponsor ID
- Neurosurgery 5 Ward
- Conditions
- Pituitary Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Wang Ying supervisor nurseUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Zhejiang University, Zhejiang Provincial People's Hospital
- Study start
- 2 Jul 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Jun 2021 (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.
(1) Objective to establish an evaluation system for predicting the risk of epistaxis after endoscopic transsphenoidal pituitary surgery（ 2) Objective to determine the risk factors of epistaxis after endoscopic transsphenoidal pituitary adenoma surgery. Referring to domestic and foreign literature, combined with experts' opinions, the related risk factors that may cause postoperative nosebleed of pituitary adenoma are: 22 patients and surgical factors. 3) Objective to establish a risk prediction model of epistaxis after endoscopic transsphenoidal pituitary tumor resection. According to the occurrence of epistaxis, the patients in the modeling group were divided into epistaxis group and non epistaxis group. The risk factors of epistaxis were taken as the independent variable, and the occurrence of epistaxis was taken as the dependent variable. The variables with statistical significance in univariate analysis were included in the multivariate logistic regression model, and the risk prediction model of epistaxis after pituitary tumor resection was established by back LR method.(4) Objective to verify the risk prediction model of endoscopic transsphenoidal pituitary adenoma epistaxis. The validation model is used to validate the prediction model, and the Hosmer-Lemeshow degree is used to match the model. The area under the receiver operating characteristic curve (ROC) was used to evaluate the validity of the model.(5) Application of risk prediction model.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epistaxis | – | –Postoperative pituitary tumor group with epistaxis |
| no epistaxis | – | –Postoperative pituitary tumor group without epistaxis |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients after transnasal sphenoidal resection of pituitary tumor
Key inclusion criteria (1 listed)
- Those who met the diagnostic criteria of pituitary tumor and received transsphenoidal endoscopic surgery during hospitalization; Patients with informed consent; Age ≥ 14 years old.
Key exclusion criteria (1 listed)
- quitters; patients with incomplete clinical data;
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 |
|---|---|---|
| Other | epistaxis, no epistaxis |
Primary outcome
Incidence of epistaxis
Time frame: up to 24 weeks
Overall incidence of epistaxis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
YIing Wang study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Tumor, run by Wang Ying supervisor nurse.
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 1 inclusion and 1 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 YIing Wang (13588837622, Ukuk007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of epistaxis (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2021.