Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors

Phase 4

Recruiting

• Conditions: Pituitary Adenoma; Pituitary Neuroendocrine Tumor
• Interventions: Drug: Hormone replacement therapy; Drug: Placebo

• Registration Number: NCT06679816
• Lead Sponsor: Beijing Tiantan Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-08
• Status Verified: 2024-12
• Study Start: 2024-12-04
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 882

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hormone supplementation therapy group	Hormone replacement therapy	-
Placebo therapy group	Placebo	-

Primary Outcome Measures

Name	Time	Method
The incidence of adrenal insufficiency on the first or second day after surgery	the first or second day after surgery

Secondary Outcome Measures

Name	Time	Method
The incidence of adrenal insufficiency within 90 days after surgery	Within 90 days after surgery

Trial Locations

Locations (1)

Beijing, Beijing Tiantan Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China