Outcome Analysis of Endoscopic Resection of Pituitary Adenomas

NCT06156020 | Unknown

• 1 other identifier: B-ER-112-452
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Keywords

pituitary adenoma

Outcome Measures

Primary Outcomes (6)

• Visual field

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

  6 months

• 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

• Cortisol level

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

  6 months

• Thyroid hormone level

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

  6 months

• Prolactin level

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

  6 months

• IGF-1 level

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

  6 months

Study Arms (1)

Endoscopic endonasal surgery

OTHER

Patients who received endoscopic endonasal resection of pituitary adenomas

Procedure: Endoscopic endonasal surgery

Interventions

Endoscopic endonasal surgery PROCEDURE

Endoscopic endonasal transsphenoidal approach for resection of pituitary adenomas

Endoscopic endonasal surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient
• Pathological diagnosis of pituitary adenoma
• Underwent endoscopic endonasal resection

You may not qualify if:

• Age \< 18 or \> 80 years
• Non-pituitary adenoma pathologies
• Underwent non-endoscopic surgery

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Related Publications (1)

• Wong CE, Chen PW, Hsu HJ, Cheng SY, Fan CC, Chen YC, Chiu YP, Lee JS, Liang SF. Collaborative Human-Computer Vision Operative Video Analysis Algorithm for Analyzing Surgical Fluency and Surgical Interruptions in Endonasal Endoscopic Pituitary Surgery: Cohort Study. J Med Internet Res. 2024 Jul 4;26:e56127. doi: 10.2196/56127.

  PMID: 38963694 DERIVED

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Central Study Contacts

Jung-Shun Lee, MD

CONTACT

+886-6-2353535; nslee1218@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 5, 2023
• Study Start: January 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)