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

NCT07015645 | Completed

• 1 other identifier: DFM-IRB 00012367-25-05-006
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Long Term; Hypopituitarism; Gamma Knife Radiosurgery; Pituitary Adenomas

Outcome Measures

Primary Outcomes (1)

• Prevalence of new-onset hypopituitarism

  Prevalence of new-onset hypopituitarism will be recorded.

  5 years post-procedure

Study Arms (1)

Pituitary Adenomas group

Patients received gamma knife radiosurgery (GKRS) treatment for pituitary adenomas.

Procedure: Gamma Knife Radiosurgery

Interventions

Gamma Knife Radiosurgery PROCEDURE

Patients received gamma knife radiosurgery (GKRS) treatment for pituitary adenomas.

Pituitary Adenomas group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort study will be conducted in the Department of Neurosurgery, Al-Azhar University Hospital.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University (Damietta)

Damietta, 0000-0001-6746-3024, Egypt

Location

MeSH Terms

Conditions

Hypopituitarism; Pituitary Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Neurosurgery, Faculty of Medicine, Al-Azhar University, Damietta, Egypt.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: January 1, 2019
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)