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Perioperative safety assessment of steroid-sparing protocol in neuroendoscopic resection for pituitary adenoma: A prospective, randomized, controlled clinical study

Perioperative safety assessment of steroid-sparing protocol in neuroendoscopic resection for pituitary adenoma: A prospective, randomized, controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078524
Enrollment
Unknown
Registered
2023-12-11
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary adenoma

Interventions

STER:200 mg Hydrocortisone (HC) was given by intravenous injection (iv) during the operation.200 mg of hydrocortisone was administered intravenously in the first 24 hours after surgery (Post-operativ
POD 3 HC 50 mg iv
POD 4 HC 25 mg iv
POD 5-14 Cortisone acetate (CA) 25 mg oral (po).
LESS-STER:Steroid hormones were not used during surgery and were grouped according to POD 1 plasma Cortisol (COR) levels at 8:00 AM (0800) : A, group SAI (COR < 5 µg/dL, or COR 5-15 µg/dL, with clini
B, group NOSAI (COR = 5 µg/dL and no clinical symptoms of adrenal cortical dysfunction) : no steroid hormones.

Sponsors

Shanghai East Hospital, School of Medicine, Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age =18 years and <80 years; Imaging diagnosis + postoperative pathology confirmed pituitary adenoma; Patients who have not received medical treatment for pituitary adenoma; All underwent neuroendoscopic transsphenoidal sinus resection (TSS); The hypothalamic-pituitary-adrenal (HPA) axis function was normal (preoperative plasma cortisol level = 5 µg/dL at 8 am (0800)) and there were no clinical symptoms of adrenal insufficiency; Patients have understood the nature of the study, voluntarily participated in this trial and signed informed consent.

Exclusion criteria

Exclusion criteria: Hypothalamic-pituitary-adrenal (HPA) axis dysfunction (preoperative at 8 am (0800) plasma cortisol levels COR < 5 µg/dL, or COR 5-15 µg/dL, Clinical symptoms associated with adrenal insufficiency (hypotension, bradycardia, nausea, fatigue, severe headache, persistent vomiting, or severe hyponatraemia (< 125 mmol/L)); Known allergic history of the drug ingredients in this study; Cushing's disease; Pituitary apoplexy; Recurrent pituitary adenoma; Invasive pituitary adenoma (Knosp III, IV or Hardy 3, 4); Previous history of craniocerebral surgery and major trauma; Patients with a history of glucocorticoid use within 4 weeks prior to surgery; Patients with prior adrenal dysfunction; Upper digestive tract bleeding from gastric ulcer; Femoral head necrosis without surgical treatment; Serious abnormal function of important organs; Nasal or intracranial infection; The pregnant woman; The researchers believe that there are any circumstances that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Ratio of newly diagnosed secondary adrenal insufficiency SAI patients on 7 days after surgery;

Secondary

MeasureTime frame
Ratio of newly diagnosed secondary adrenal insufficiency SAI patients on 14 days after surgery;

Countries

China

Contacts

Public ContactChunlong Zhong

Shanghai East Hospital, School of Medicine, Tongji University

drchunlongzhong@tongji.edu.cn+86 135 0167 7469

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026