Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Pituitary Adenoma, Pituitary Neuroendocrine Tumor
In brief
The goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. The main questions it aims to answer are: • Does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants? Researchers will compare hydrocortisone to a placebo (a look-alike substance that contains no drug) to see if hydrocortisone works to reduce the incidence of adrenal insufficiency. Participants will: * Take or intravenous infusion drug hydrocortisone or a placebo every day for 2 weeks * Visit the clinic three months after surgery for checkups and tests * Keep a diary of their symptoms
Key facts
- Study ID
- NCT06679816
- Run by
- Beijing Tiantan Hospital
- People needed
- 882
- Starts
- 2024-12-04
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-01-14
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- (1) Age range: 18-70 years old;
- (2) Accept PitNETs patients who can be treated with endoscopic transsphenoidal surgery;
- (3) The maximum diameter of the tumor is ≥ 2 centimeters;
- (4) Preoperative hypothalamic pituitary adrenal axis integrity;
- (5) The subject or their legal representative signs the informed consent form
You may not qualify if…
- (1) Patients with a history of Cushing's disease or adrenal insufficiency;
- (2) Emergency and combined hormone therapy patients;
- (3) Pituitary stroke patients;
- (4) Patients lacking head magnetic resonance imaging;
Where it is running
- Beijing, Beijing Tiantan Hospital,Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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