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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06679816

Enrollment

882

Registered

2024-11-08

Start date

2024-12-04

Completion date

2026-06-30

Last updated

2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Adenoma, Pituitary Neuroendocrine Tumor

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

Interventions

DRUGHormone replacement therapy

Perioperative Hydrocortisone Reduction Therapy

DRUGPlacebo

Perioperative placebo Reduction Therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Secondary

Measure	Time frame
The incidence of adrenal insufficiency within 90 days after surgery	Within 90 days after surgery

Countries

China

Contacts

Primary Contactxingchao wang, Phd

wangxc@mail.ccmu.edu.cn15101053127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026