Evaluating Hydrocortisone Replacement Therapy During Surgery for Large Pituitary Neuroendocrine Tumors A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 4 Study

What this Trial Is About

Researchers are evaluating whether hydrocortisone replacement therapy is needed during the perioperative period for patients with large pituitary neuroendocrine tumors. This Phase 4 clinical trial aims to determine if hydrocortisone reduces the risk of adrenal insufficiency after surgery compared to a placebo. The study is led by Beijing Tiantan Hospital and will help clarify hormone replacement strategies around surgery for these tumors. Participants will be randomly assigned to receive either hydrocortisone or a placebo through oral or intravenous infusion daily for two weeks starting around the time of surgery. The study has a double-blind design, meaning neither participants nor researchers know who receives hydrocortisone or placebo. After surgery and treatment, participants will return for follow-up visits, including a checkup three months later. During the trial, participants will keep a symptom diary and undergo tests to monitor adrenal function. The primary outcome is the rate of adrenal insufficiency within the first two days after surgery, with additional evaluation within 90 days. This helps researchers understand the effects of hormone supplementation on recovery. The total study duration includes treatment and follow-up to ensure safety and effectiveness monitoring.

Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors