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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pituitary Neoplasms Craniopharyngiomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A. Normal function, non-GC replacement

No glucocorticoid replacement will be given perioperatively.

Group Type NO_INTERVENTION

No interventions assigned to this group

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;

Group Type ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type DRUG

used intravenously

Prednisone

Intervention Type DRUG

used as tablet form

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;

Group Type ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type DRUG

used intravenously

Prednisone

Intervention Type DRUG

used as tablet form

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.

Group Type ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type DRUG

used intravenously

Prednisone

Intervention Type DRUG

used as tablet form

Interventions

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Hydrocortisone

used intravenously

Intervention Type DRUG

Prednisone

used as tablet form

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No