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Clinical Trials/NCT06679816
NCT06679816
Recruiting
Phase 4

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

Beijing Tiantan Hospital1 site in 1 country882 target enrollmentDecember 4, 2024

Overview

Phase
Phase 4
Intervention
Hormone replacement therapy
Conditions
Pituitary Adenoma
Sponsor
Beijing Tiantan Hospital
Enrollment
882
Locations
1
Primary Endpoint
The incidence of adrenal insufficiency on the first or second day after surgery
Status
Recruiting
Last Updated
last year

Overview

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
Registry
clinicaltrials.gov
Start Date
December 4, 2024
End Date
June 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Tiantan Hospital
Responsible Party
Sponsor

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;

Arms & Interventions

Hormone supplementation therapy group

Intervention: Hormone replacement therapy

Placebo therapy group

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: the first or second day after surgery

Secondary Outcomes

  • The incidence of adrenal insufficiency within 90 days after surgery(Within 90 days after surgery)

Study Sites (1)

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