Long-Term Outcomes of Hypopituitarism Following Gamma Knife Radiosurgery for Pituitary Adenomas

Completed

• Conditions: Long Term; Hypopituitarism; Gamma Knife Radiosurgery; Pituitary Adenomas

• Registration Number: NCT07015645
• Lead Sponsor: Al-Azhar University

Brief Summary

This study aims to assess long-term outcomes of hypopituitarism following gamma knife radiosurgery (GKRS) for pituitary adenomas.

Detailed Description

Pituitary adenomas (PAs) are one of the most common intracranial neoplasms, accounting for 10-20% of diagnosed brain tumors.

Initial gamma knife radiosurgery (GKRS) can be an alternative treatment for selected NFPA patients with comorbidities, documented growth small tumors, cavernous sinus invasion, or advanced age.

Hypopituitarism is one of the most common complications of radiosurgery (Cordeiro et al., 2018). Long-term follow-up is crucial to assess new pituitary deficits. Typically, hypopituitarism presents within the first 2-4 years after the treatment with radiosurgery, but the risk of pituitary insufficiency increases to up to 80%. Reports on the highest incidence of new-onset hypopituitarism also mentioned the longest follow-up period.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Age ≥18 years.
• Both sexes.
• Patients treated with gamma knife radiosurgery (GKRS).

Exclusion Criteria

• Patients with inadequate endocrine follow-up (<12 months).
• Patients who had undergone previous radiation therapy.
• Pituitary insufficiency which presents before gamma knife radiosurgery (GKRS).
• Patients without visible glands.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of new-onset hypopituitarism	5 years post-procedure	Prevalence of new-onset hypopituitarism will be recorded.

Trial Locations

Locations (1)

Al-Azhar University (Damietta); 🇪🇬 Damietta, Egypt