Hydrocortisone Use During Peri-operation for Pituitary Adenomas

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Adrenal Insufficiency; Surgery; Pituitary Adenoma

Treatments: Drug: Normal saline; Drug: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT04621565

ZS-2608

Details and patient eligibility

About

The investigators hypothesize that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose hypothalamus pituitary adrenal axis are intact are safe.

Full description

Pituitary is the headquarters of the endocrine system of the body, secreting several hormones maintaining the normal function of the endocrine organs. After surgery, pituitary dysfunction is seen in a small proportion of patients, even in some patients resulting in severe consequence, i.e. adrenal insufficiency or pituitary crisis. Therefore, patients undergoing pituitary surgery have been usually given "stress dose" steroids whether their hypothalamus pituitary adrenal (HPA) axis are deficient or preserved.

Results of several retrospective studies showed that there was no significantly increase in postoperative adrenal insufficiency in no supplementation (of hydrocortisone) group than in supplementation group. Given the considerable side effects of using steroids, whether hydrocortisone administration is necessary for all patients with pituitary adenomas during peri-operation needs to be discussed.

For Chinese patients with pituitary adenomas except for those of Cushing's disease, hydrocortisone administration during the peri-operation is a routine practice. Peking Union Medical College Hospital is the China Pituitary Disease Registry Center. Here, the investigators aim to launch a single-center prospective randomized controlled trial to verify the hypothesis that withholding hydrocortisone during the peri-operation in patients with pituitary adenomas whose HPA axis are intact are safe.

Enrollment: 436 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with pituitary adenomas that need surgical resection of the tumor, whose hypothalamus-pituitary-adrenal axis are intact
• Patients of either gender aged from 18 years to 70 years

Exclusion criteria

• Patients with Cushing's disease
• Patients with pituitary adenomas who have already developed secondary adrenal insufficiency before surgery
• Patients with pituitary apoplexy or other acute pituitary conditions that need emergency surgery
• The postoperative pathology result indicates that the tumor is not a pituitary adenoma
• Patients that refuse to participate in the study or those who ask to quit after enrollment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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436 participants in 2 patient groups

Hydrocortisone withholding group

Experimental group

Description:

Patients receive no hydrocortisone

Treatment:

Drug: Normal saline

Hydrocortisone group

Active Comparator group

Description:

Patients receive routine hydrocortisone

Treatment:

Drug: Hydrocortisone