NCT06679816 Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
| NCT ID | NCT06679816 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Pituitary Adenoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 882 participants |
| Start Date | 2024-12-04 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 882 participants in total. It began in 2024-12-04 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06679816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Pituitary Adenoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06679816 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06679816 currently recruiting?
Yes, NCT06679816 is actively recruiting participants. Contact the research team at wangxc@mail.ccmu.edu.cn for enrollment information.
Where is the NCT06679816 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06679816 clinical trial?
NCT06679816 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 882 participants.