Surgery versus surveillance in subclinical Cushing's syndrome
Research type
Research Study
Full title
Prospective randomized study of adrenalectomy compared with follow-up in patients with subclinical Cushing's syndrome (AUSC)
IRAS ID
221966
Contact name
Ulf Malmqvist
Contact email
Sponsor organisation
Skane University Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
Adrenal incidentalomas, adrenal tumours detected without symptoms and signs of hormonal hypersecretion or malignancy, are common. Depending on modality (MRI, CT, Ultrasonography) adrenal tumours occur in approximately 1-5% of the population. In about 10% of patients, the tumours are bilateral. At autopsy studies, adrenal tumours occur in 1% of patients under the age of 30, but in approximately 7% of patients older than 70 years. Investigation of the adrenal tumours focus on to exclude malignancy (which is uncommon), and an increased secretion of hormones (adrenaline, aldosterone, cortisol), so-called functional tumours. However, most often adrenal incidentalomas are non-functional. The most common functional disorder is increased secretion of cortisol, and then usually without clinical stigmata, known as subclinical Cushing's syndrome (or mild hypercortisolism). Clinical stigmata, Cushing's syndrome, is empirically associated with elevated levels of urinary cortisol.
Subclinical Cushing's syndrome occurs in 10-25% of patients with adrenal incidentalomas. The incidence has been estimated at 0.8 / 1,000 inhabitants, making it a common disease.
Diagnosis is based to detect an autonomous release of cortisol from the adrenal gland (a disorder of the so-called hypothalamic-pituitary-adrenal axis).
It remains unknown whether patients with autonomous cortisol secretion benefit from removal of the cortisol-producing adenoma. The only randomised-controlled trial to date showed improvement in hypertension, but definitions of other important outcomes were subjective and did not show statistical significance similar to observational data reported by others. Furthermore, the study lacked a primary outcome measure and statistical power calculation was missing.
The main aim of this study is to determine whether adrenalectomy for subclinical Cushing's syndrome (mild hypercortisolism without clinical signs) results in an improvement of cardiovascular risk factors, cardiac function, and arteriosclerosis compared patients managed conservatively.REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1195
Date of REC Opinion
10 Sep 2018
REC opinion
Further Information Favourable Opinion