RecruitingPhase 4NCT06679816

Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine 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

Sponsor

Beijing Tiantan Hospital

Enrollment

882 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Pituitary Adenoma Pituitary Neuroendocrine Tumor

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a stress hormone called hydrocortisone during and after surgery helps people recover better from an operation to remove a large pituitary tumor (a non-cancerous growth at the base of the brain). **You may be eligible if...** - You are between 18 and 70 years old - You have a pituitary tumor at least 2 cm in size that can be removed through the nose (endoscopic transsphenoidal surgery) - Your body's natural cortisol (stress hormone) system is working normally before surgery **You may NOT be eligible if...** - You have a history of Cushing's disease or adrenal insufficiency (conditions where your body already makes too much or too little cortisol) - You need emergency surgery or are already on combined hormone therapy - You have had a pituitary stroke - You do not have MRI scans of your brain Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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