Outcome Analysis of Endoscopic Resection of Pituitary Adenomas

March 20, 2024 updated by: National Cheng-Kung University Hospital

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng-Kung University Hospital
        • Contact:
          • Jung-Shun Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: Endoscopic endonasal surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 24, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-ER-112-452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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