Using hydrocortisone for hormone therapy in patients with large pituitary tumors
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
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 |
| Enrollment | 882 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06679816 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with large pituitary neuroendocrine tumors suitable for endoscopic transsphenoidal surgery.
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.
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 performed: While this approach is being evaluated in this specific context, similar studies on hormone replacement therapy have shown promise in managing adrenal insufficiency.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.