Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
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.