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

Pituitary Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02190994
• Other study ID #: WestChina-2013137
• Status: Recruiting
• Phase: Phase 4
• First received: July 5, 2014
• Last updated: July 11, 2014
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: West China Hospital
• Contact: Senlin Yin, M.D.
• Phone: +86 13072808795
• Email: enforest[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniopharyngioma
• Craniopharyngiomas
• Pituitary Neoplasms

Intervention

Drug:
• Hydrocortisone
used intravenously
• Prednisone
used as tablet form

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline plasma cortisol level	Plasma cortisol at 8:00, 16:00, 24:00 respectively	1, 3, 5, 7, 30, 90, 180, 360 days post-op	No
Primary	Change from baseline plasma ACTH level	ACTH at 8:00;	1, 3, 5, 7, 30, 90, 180, 360 days post-op	No
Primary	Change from baseline 24-hour urine free cortisol	24-hour urine free cortisol	1, 3, 5, 7, 30, 90, 180, 360 days post-op	No
Primary	Change from baseline insulin tolerance test result	insulin tolerance test result	7, 30, 90 days post-op	No
Secondary	Change from baseline plasma TSH level	plasma TSH level	1, 3, 5, 7, 30, 90, 180, 360 days post-op	No
Secondary	Sodium, potassium concentration in the blood and urine	Concentration of sodium, potassium in the blood and urine	Daily post-op,for the duration of hospital stay, an expected average of 7 days	No
Secondary	Number of patients with postoperative infection	Routine blood test, body temperature fluctuation, cerebrospinal fluid test if necessary.	For the duration of hospital stay, an expected average of 7 days	No
Secondary	Change from baseline health-related quality of life	The 15-Dimensions measure of health-related quality of life	7, 30, 90 days post-op	No
Secondary	Number of patients with recurred tumor	Enhanced MRI scan of the sellar region.	3,6,12 months after surgery	No
Secondary	Change from baseline plasma free T3 level	plasma free T3 level	1, 3, 5, 7, 30, 90, 180, 360 days post-op	No
Secondary	Change from baseline plasma free T4 level	plasma free T4 level	1, 3, 5, 7, 30, 90, 180, 360 days post-op	No
Secondary	Urine output	24-hour urine output	Daily post-op,for the duration of hospital stay, an expected average of 7 days	No