Hydrocortisone Use During Peri-operation for Pituitary Adenomas

Phase

N/A

Condition

Surgery

Hormone Deficiencies

Cushing's Disease

Treatment

N/A

Clinical Study ID

NCT04621565

ZS-2608

Ages 18-70
All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Patients with Cushing's disease
Patients with pituitary adenomas who have already developed secondary adrenalinsufficiency before surgery
Patients with pituitary apoplexy or other acute pituitary conditions that needemergency 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 afterenrollment

Study Design

November 01, 2020

July 31, 2022

Study 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.

Connect with a study center

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing 100730
China
Active - Recruiting

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