Using hydrocortisone for hormone therapy in patients with large pituitary tumors
Official title: Study on the Efficacy of Hydrocortisone in Perioperative Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors:a Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled Study
Run by Beijing Tiantan Hospital · NCT06679816 · Data updated 2026-11-12
This study is testing if giving hydrocortisone to patients with large pituitary tumors before and after surgery can help prevent adrenal problems compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 882 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | December 4, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | January 14, 2025 |
| Trial ID | NCT06679816 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-70 with large pituitary neuroendocrine tumors suitable for endoscopic transsphenoidal surgery.
✕Probably not a fit
Patients with a history of Cushing's disease, adrenal insufficiency, or those requiring emergency hormone therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the necessity of hydrocortisone replacement therapy during the perioperative period for patients undergoing surgery for large pituitary neuroendocrine tumors. Participants will receive either hydrocortisone or a placebo daily for two weeks and will be monitored for signs of adrenal insufficiency. Follow-up visits will occur three months post-surgery to assess outcomes and participants will maintain a diary of their symptoms throughout the study.
Why it matters
Potential benefit: If successful, this study could help prevent adrenal insufficiency in patients undergoing surgery for large pituitary tumors.
How similar studies have gone: While this approach is being evaluated in this specific context, similar studies on hormone replacement therapy have shown promise in managing adrenal insufficiency.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * (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 Exclusion Criteria: * (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's running
-
Beijing, Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: xingchao wang, Phd
- Email: wangxc@mail.ccmu.edu.cn
- Phone: 15101053127
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.