Craniopharyngiomas, Pituitary Neoplasms
Conditions
Keywords
Hydrocortisone, Pituitary adenomas, Replacement therapy
Brief 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.
Interventions
DRUGHydrocortisone
used intravenously
DRUGPrednisone
used as tablet form
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline plasma ACTH level | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | ACTH at 8:00; |
| Change from baseline 24-hour urine free cortisol | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | 24-hour urine free cortisol |
| Change from baseline insulin tolerance test result | 7, 30, 90 days post-op | insulin tolerance test result |
| Change from baseline plasma cortisol level | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | Plasma cortisol at 8:00, 16:00, 24:00 respectively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with recurred tumor | 3,6,12 months after surgery | Enhanced MRI scan of the sellar region. |
| Change from baseline plasma free T3 level | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | plasma free T3 level |
| Change from baseline plasma TSH level | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | plasma TSH level |
| Urine output | Daily post-op,for the duration of hospital stay, an expected average of 7 days | 24-hour urine output |
| Change from baseline plasma free T4 level | 1, 3, 5, 7, 30, 90, 180, 360 days post-op | plasma free T4 level |
| Sodium, potassium concentration in the blood and urine | Daily post-op,for the duration of hospital stay, an expected average of 7 days | Concentration of sodium, potassium in the blood and urine |
| Number of patients with postoperative infection | For the duration of hospital stay, an expected average of 7 days | Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary. |
| Change from baseline health-related quality of life | 7, 30, 90 days post-op | The 15-Dimensions measure of health-related quality of life |
Countries
China
Contacts
Primary ContactSenlin Yin, M.D.
Outcome results
None listed