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

Sponsor

West China Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02190994

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pituitary Neoplasms Craniopharyngiomas	Drug: Hydrocortisone Drug: Prednisone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: A. Normal function, non-GC replacement No glucocorticoid replacement will be given perioperatively.
Active Comparator: B. Normal function, low-dose GC Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;	Drug: Hydrocortisone used intravenously Drug: Prednisone used as tablet form
Active Comparator: C. Impaired function, low-dose GC Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1. 80mg hydrocortisone at day 2; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet at day 4 and day 5; 2.5mg at day 6;	Drug: Hydrocortisone used intravenously Drug: Prednisone used as tablet form
Active Comparator: D. Impaired function, high-dose GC Hydrocortisone 100mg i.v. before anesthesia induction, and postoperative day 1 and day 2. 60mg hydrocortisone at day 3; 60mg at day 3; 20mg at day 4; 5mg oral prednisone acetate tablet per day, since postoperative day 3.	Drug: Hydrocortisone used intravenously Drug: Prednisone used as tablet form

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change from baseline plasma TSH level [1, 3, 5, 7, 30, 90, 180, 360 days post-op]
plasma TSH 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
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 free T4 level [1, 3, 5, 7, 30, 90, 180, 360 days post-op]
plasma free T4 level
Urine output [Daily post-op,for the duration of hospital stay, an expected average of 7 days]
24-hour urine output

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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