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

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

Inclusion Criteria5

  • (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 Criteria4

  • (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;

Interventions

DRUGHormone replacement therapy

Perioperative Hydrocortisone Reduction Therapy

DRUGPlacebo

Perioperative placebo Reduction Therapy


Locations(1)

Beijing, Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06679816


Related Trials