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CompletedNCT07015645Updated Jun 11, 2025

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

An observational study in Long Term, Hypopituitarism and Gamma Knife Radiosurgery, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
137
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Long Term
  • Hypopituitarism
  • Gamma Knife Radiosurgery
  • Pituitary Adenomas
03

In context

Hypopituitarism

47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.

This study's enrollment of 137 is close to the median of 137 across 17 observational studies indexed under Hypopituitarism.

Browse Hypopituitarism studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
137 participants (actual)
Patient registry
No

Groups and cohorts

  • Pituitary Adenomas group

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

    Procedure: Gamma Knife Radiosurgery

Interventions

  • ProcedureGamma Knife Radiosurgery

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

06

What researchers measure

Primary outcomes

  1. Prevalence of new-onset hypopituitarism

    Prevalence of new-onset hypopituitarism will be recorded.

    Time frame: 5 years post-procedure

07

Study locations

1 site
  • Al-Azhar University (Damietta)
    Damietta, 0000-0001-6746-3024, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Jan 2025, 72 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2025
First posted
Jun 11, 2025
StartActual
Jan 1, 2019
Primary completionActual
Jan 1, 2025
CompletionActual
Jan 1, 2025
Last update
Jun 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07015645
Responsible party
Awad Mohamed Hegab (Lecturer of Neurosurgery, Faculty of Medicine, Al-Azhar University, Damietta, Egypt., Al-Azhar University) — Principal investigator
First posted
Jun 11, 2025
Start date
Jan 1, 2019
Primary completion
Jan 1, 2025
Completion
Jan 1, 2025
Last update
Jun 11, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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