Clinical trial NCT02190994: Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
Official title: Effect of Perioperative Glucocorticoid Replacement on Prognosis of Surgical Patients With Sellar Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pituitary Neoplasms
Craniopharyngiomas
Keywords: Hydrocortisone
Pituitary adenomas
Replacement therapy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline plasma cortisol level
timeFrame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
measure: Change from baseline plasma ACTH level
timeFrame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
measure: Change from baseline 24-hour urine free cortisol
timeFrame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
measure: Change from baseline insulin tolerance test result
timeFrame: 7, 30, 90 days post-op
Secondary outcomes:
measure: Change from baseline plasma TSH level
timeFrame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
measure: Sodium, potassium concentration in the blood and urine
timeFrame: Daily post-op,for the duration of hospital stay, an expected average of 7 days
measure: Number of patients with postoperative infection
timeFrame: For the duration of hospital stay, an expected average of 7 days
measure: Change from baseline health-related quality of life
timeFrame: 7, 30, 90 days post-op
measure: Number of patients with recurred tumor
timeFrame: 3,6,12 months after surgery
measure: Change from baseline plasma free T3 level
timeFrame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
measure: Change from baseline plasma free T4 level
timeFrame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op
measure: Urine output
timeFrame: Daily post-op,for the duration of hospital stay, an expected average of 7 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital, Sichuan University, Chengdu, Sichuan, PR China
name: Shu Jiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: