Neoplasms

All Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Rare Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Craniopharyngioma

Adamantinoma

Ameloblastoma

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Bone Neoplasms

Bone Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Neuroepithelioma

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Anesthetics

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

No glucocorticoid replacement will be given perioperatively.

Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;

Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3.

Senlin Yin, M.D.

Shu Jiang, M.D.

Peizhi Zhou, M.D.

The purpose of this four-arm randomized controlled study is to determine whether eliminating glucocorticoids (GC) replacement in perioperative period in surgical patients with sellar lesion could result in similar or better outcomes comparing to traditional replacement therapy, regarding postoperative recovery of pituitary function and other postoperative complications (infection, pain, quality of life, recurrence). Surgical patients of our center with MRI-confirmed diagnosis of sellar lesion will be enrolled, insulin tolerance test (ITT) will be performed for assessment of the pituitary function at enrollment. Patients with normal pituitary function will be randomized into non-GC replacement group (group A) and low-dose GC replacement group (group B), while patients with impaired pituitary function will be randomized into low-dose GC replacement group (group C) and high-dose GC replacement group (group D). The primary outcome is the hypothalamic-pituitary-adrenal (HPA) -axis function of the patients, evaluated by plasma cortisol and adrenocorticotropic hormone (ACTH) levels. The secondary outcomes include the hypothalamic-pituitary-thyroid (HPT) axis function (TSH, thyroid-stimulating hormone, free T3, free T4), postoperative water-electrolyte balance, infection, recurrence and health-related quality of life.

Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions

Plasma cortisol at 8:00, 16:00, 24:00 respectively

Concentration of sodium, potassium in the blood and urine

Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.

The 15-Dimensions measure of health-related quality of life

West China Hospital

Professor Shu Jiang

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions	NCT02190994	Pituitary Neopl... Craniopharyngio...	Hydrocortisone Prednisone	18 Years -	West China Hospital
Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions	NCT02190994	Pituitary Neopl... Craniopharyngio...	Hydrocortisone Prednisone	18 Years -	West China Hospital

Spots Global Cancer Trial Database for replacement therapy