- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06156020
Outcome Analysis of Endoscopic Resection of Pituitary Adenomas
Analysis of Operative Outcomes Following Endoscopic Resection of Pituitary Adenomas
The goal of this prospective study is to learn about the operative outcomes in patients with pituitary adenoma who receive endoscopic resection.
The main question it aims to answer is:
• What are the outcomes of patient following endoscopic resection? including visual, hormonal, survival, and functional outcomes.
Participants' data including clinical history, laboratory data, radiographic images, intraoperative videos will be evaluated and analyzed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jung-Shun Lee, MD
- Phone Number: 5291 +886-6-2353535
- Email: nslee1218@gmail.com
Study Locations
-
-
-
Tainan, Taiwan, 704
- Recruiting
- National Cheng-Kung University Hospital
-
Contact:
- Jung-Shun Lee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patient
- Pathological diagnosis of pituitary adenoma
- Underwent endoscopic endonasal resection
Exclusion Criteria:
- Age < 18 or > 80 years
- Non-pituitary adenoma pathologies
- Underwent non-endoscopic surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Endoscopic endonasal surgery
Patients who received endoscopic endonasal resection of pituitary adenomas
|
Endoscopic endonasal transsphenoidal approach for resection of pituitary adenomas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual field
Time Frame: 6 months
|
The postoperative visual field will be assessed with standard visual perimetry and compared with preoperative measurements.
|
6 months
|
Diabetes insipidus
Time Frame: 6 months
|
Postoperatively, the patient's urine output and urine specific gravity will be measured to determine if the patient had diabetes insipidus.
If the patient had diabetes insipidus, the duration of the diabetes insipidus will be recorded.
|
6 months
|
Cortisol level
Time Frame: 6 months
|
Postoperative serum cortisol level will be measured and compared to preoperative levels.
|
6 months
|
Thyroid hormone level
Time Frame: 6 months
|
Postoperative serum TSH and free T4 level will be measured and compared to preoperative levels.
|
6 months
|
Prolactin level
Time Frame: 6 months
|
Postoperative serum prolactin level will be measured and compared to preoperative levels.
|
6 months
|
IGF-1 level
Time Frame: 6 months
|
Postoperative serum IGF-1 level will be measured and compared to preoperative levels.
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Adenoma
- Pituitary Neoplasms
- Pituitary Diseases
Other Study ID Numbers
- B-ER-112-452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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