Outcome Analysis of Endoscopic Resection of Pituitary Adenomas

• Sponsor: National Cheng-Kung University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06156020
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 47
• Patients Per Site Per Month: 10.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pituitary Adenoma	Procedure: Endoscopic endonasal surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Analysis of Operative Outcomes Following Endoscopic Resection of Pituitary Adenomas
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Endoscopic endonasal surgery Patients who received endoscopic endonasal resection of pituitary adenomas	Procedure: Endoscopic endonasal surgery; Endoscopic endonasal transsphenoidal approach for resection of pituitary adenomas

Outcome Measures

Primary Outcome Measures

1. Visual field [6 months]

   The postoperative visual field will be assessed with standard visual perimetry and compared with preoperative measurements.

2. 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.

3. Cortisol level [6 months]

   Postoperative serum cortisol level will be measured and compared to preoperative levels.

4. Thyroid hormone level [6 months]

   Postoperative serum TSH and free T4 level will be measured and compared to preoperative levels.

5. Prolactin level [6 months]

   Postoperative serum prolactin level will be measured and compared to preoperative levels.

6. IGF-1 level [6 months]

   Postoperative serum IGF-1 level will be measured and compared to preoperative levels.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng-Kung University Hospital	Tainan		Taiwan	704

Sponsors and Collaborators

• National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT06156020
• Other Study ID Numbers: B-ER-112-452
• First Posted: Dec 5, 2023
• Last Update Posted: Dec 5, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Cheng-Kung University Hospital: pituitary adenoma
• Additional relevant MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases

Study Results

No Results Posted as of Dec 5, 2023