Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Pituitary Neuroendocrine Tumor | Pituitary Neuroendocrine Tumor | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hormone replacement therapy | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hormone supplementation therapy group
- interventionNames
- Drug: Hormone replacement therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo therapy group
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The incidence of adrenal insufficiency on the first or second day after surgery
- timeFrame
- the first or second day after surgery
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available