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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: West China Hospital

Current Primary Outcome:

  • Change from baseline plasma cortisol level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    Plasma cortisol at 8:00, 16:00, 24:00 respectively
  • Change from baseline plasma ACTH level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    ACTH at 8:00;
  • Change from baseline 24-hour urine free cortisol [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    24-hour urine free cortisol
  • Change from baseline insulin tolerance test result [ Time Frame: 7, 30, 90 days post-op ]
    insulin tolerance test result


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline plasma TSH level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    plasma TSH level
  • Sodium, potassium concentration in the blood and urine [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 7, 30, 90 days post-op ]
    The 15-Dimensions measure of health-related quality of life
  • Number of patients with recurred tumor [ Time Frame: 3,6,12 months after surgery ]
    Enhanced MRI scan of the sellar region.
  • Change from baseline plasma free T3 level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    plasma free T3 level
  • Change from baseline plasma free T4 level [ Time Frame: 1, 3, 5, 7, 30, 90, 180, 360 days post-op ]
    plasma free T4 level
  • Urine output [ Time Frame: Daily post-op,for the duration of hospital stay, an expected average of 7 days ]
    24-hour urine output


Original Secondary Outcome: Same as current

Information By: West China Hospital

Dates:
Date Received: July 5, 2014
Date Started: August 2013
Date Completion: December 2014
Last Updated: July 11, 2014
Last Verified: July 2014