Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hormone replacement therapy, Placebo.
- Who it may be relevant to
- Registry conditions: Pituitary Adenoma, Pituitary Neuroendocrine Tumor. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug Hormone replacement therapy
Perioperative Hydrocortisone Reduction Therapy - Drug Placebo
Perioperative placebo Reduction Therapy
Primary outcome measures
- The incidence of adrenal insufficiency on the first or second day after surgery [Time frame: the first or second day after surgery]
Secondary outcome measures (1)
- The incidence of adrenal insufficiency within 90 days after surgery [Time frame: Within 90 days after surgery]
Eligibility 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Beijing, Beijing Tiantan Hospital,Capital Medical University — Beijing
Identifiers
NCT: NCT06679816 · HEALTH