Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Tiantan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
(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;
Disqualifiers
(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;
Trial design
Design model
Parallel
Treatments tested in this trial
Hormone replacement therapy
DrugPerioperative Hydrocortisone Reduction Therapy
Placebo
DrugPerioperative placebo Reduction Therapy
Treatment groups
882 Participants
are divided into 2 treatment groupsGroup A: Hormone supplementation therapy groupExperimental treatment 1 intervention
Group B: Placebo therapy groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of adrenal insufficiency on the first or second day after surgery
Time frame
the first or second day after surgerySecondary outcomes
1
The incidence of adrenal insufficiency within 90 days after surgery
Time frame
Within 90 days after surgerySponsors and contacts
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Source ClinicalTrials.gov