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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• (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

Locations
Other Locations
China
Beijing, Beijing Tiantan Hospital,Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
xingchao wang, Phd
wangxc@mail.ccmu.edu.cn
15101053127
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 882
Treatments
Experimental: Hormone supplementation therapy group
Placebo_comparator: Placebo therapy group
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials