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NCT Number: NCT06679816

Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors

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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Key information

Conditions

Pituitary Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Pituitary Neuroendocrine Tumor Supratentorial Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

xingchao wang, Dr

CONTACT

[email protected]

15101053127

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

hormone replacement therapy

Drug

Perioperative Hydrocortisone Reduction Therapy

Placebo

Drug

Perioperative placebo Reduction Therapy

Primary outcomes

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

    Time frame: the first or second day after surgery

Secondary outcomes

  1. The incidence of adrenal insufficiency within 90 days after surgery

    Time frame: Within 90 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

xingchao wang, Phd

CONTACT

[email protected]

15101053127

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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