Outcome Analysis of Endoscopic Resection of Pituitary Adenomas

Pituitary Adenoma Clinical Trial

Official title:

Analysis of Operative Outcomes Following Endoscopic Resection of Pituitary Adenomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156020
• Other study ID #: B-ER-112-452
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: National Cheng-Kung University Hospital
• Contact: Jung-Shun Lee, MD
• Phone: +886-6-2353535
• Email: nslee1218[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Procedure:
• Endoscopic endonasal surgery
Endoscopic endonasal transsphenoidal approach for resection of pituitary adenomas

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual field	The postoperative visual field will be assessed with standard visual perimetry and compared with preoperative measurements.	6 months
Primary	Diabetes insipidus	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
Primary	Cortisol level	Postoperative serum cortisol level will be measured and compared to preoperative levels.	6 months
Primary	Thyroid hormone level	Postoperative serum TSH and free T4 level will be measured and compared to preoperative levels.	6 months
Primary	Prolactin level	Postoperative serum prolactin level will be measured and compared to preoperative levels.	6 months
Primary	IGF-1 level	Postoperative serum IGF-1 level will be measured and compared to preoperative levels.	6 months