Outcome Analysis of Endoscopic Resection of Pituitary Adenomas

Not Applicable

Recruiting

• Conditions: Pituitary Adenoma
• Interventions: Procedure: Endoscopic endonasal surgery

• Registration Number: NCT06156020
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-24
• Study First Posted: 2023-12-05
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic endonasal surgery	Endoscopic endonasal surgery	Patients who received endoscopic endonasal resection of pituitary adenomas

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan