Overview

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

Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
West China Hospital
Treatments:
Cortisol succinate
Glucocorticoids
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Prednisone
Criteria
Inclusion Criteria:

- Age >= 18

- Surgical patients with MRI-confirmed diagnosis of sellar lesions (non-functioning
pituitary adenoma or craniopharyngioma)

Exclusion Criteria:

- Patients with pre-existing hyperthyroidism or Cushing's syndrome

- Patients with long-term glucocorticoids replacement history

- Patients with other co-morbidities that pose known influence upon the HPA-axis
function (cardiovascular or cerebrovascular disease, metabolic disease or epilepsy)

- Patients with severe panhypopituitarism

- Patients with history of radiotherapy of the pituitary gland