Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

882 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-04

Study Completion Date

2026-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Pituitary Adenoma Pituitary Neuroendocrine Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Hormone supplementation therapy group

Group Type EXPERIMENTAL

Hormone replacement therapy

Intervention Type DRUG

Perioperative Hydrocortisone Reduction Therapy

Placebo therapy group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Perioperative placebo Reduction Therapy

Interventions

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Hormone replacement therapy

Perioperative Hydrocortisone Reduction Therapy

Intervention Type DRUG

Placebo

Perioperative placebo Reduction Therapy

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No