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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
used intravenously
used as tablet form
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGChange from baseline plasma cortisol level
Plasma cortisol at 8:00, 16:00, 24:00 respectively
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline plasma ACTH level
ACTH at 8:00;
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline 24-hour urine free cortisol
24-hour urine free cortisol
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline insulin tolerance test result
insulin tolerance test result
Time frame: 7, 30, 90 days post-op
Change from baseline plasma TSH level
plasma TSH level
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Sodium, potassium concentration in the blood and urine
Concentration of sodium, potassium in the blood and urine
Time frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days
Number of patients with postoperative infection
Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.
Time frame: For the duration of hospital stay, an expected average of 7 days
Change from baseline health-related quality of life
The 15-Dimensions measure of health-related quality of life
Time frame: 7, 30, 90 days post-op
Number of patients with recurred tumor
Enhanced MRI scan of the sellar region.
Time frame: 3,6,12 months after surgery
Change from baseline plasma free T3 level
plasma free T3 level
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Change from baseline plasma free T4 level
plasma free T4 level
Time frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
Urine output
24-hour urine output
Time frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days
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