Trial Information
Adrenalectomy Versus Follow-up in Patients With Mild Hypercortisolism: a Prospective Randomized Controlled Trial
Inclusion Criteria:
- Adrenal tumour with biochemical mild hypercortisolism defined as pathological
dexamethasone suppression test (cortisol > 50 nmol/L at 8.00 am after 1 mg
dexamethasone at 10 pm, plus one of the following criteria
- Low or suppressed adrenocorticotropic hormone (ACTH)
- Low or suppressed dehydroepiandrosterone (DHEA)
- No or pathological circadian rhythm of cortisol
Exclusion Criteria:
- Increased levels of 24 hours urinary excretion of cortisol
- Pregnancy or lactation
- Inability to understand information or to comply with scheduled follow-up
- Mild hypercortisolism with bilateral adrenal tumours, without a gradient
(lateralization on venous sampling)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Normalization of hypertension
Outcome Description:
Normalization of hypertension according to classification of the World Health Organization (WHO) assessed by 24 hours blood pressure measurement.
Outcome Time Frame:
At two years after intervention
Safety Issue:
No
Principal Investigator
Anders OJ Bergenfelz, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Surgery, Skåne University Hospital, Lund, Sweden
Authority:
Sweden: The National Board of Health and Welfare
Study ID:
2010/297
NCT ID:
NCT01246739
Start Date:
June 2011
Completion Date:
January 2015
Related Keywords:
- Adrenal Tumour With Mild Hypercortisolism
- mild hypercortisolism
- adrenal tumour
- surgical procedures, elective
- indication
- Adrenocortical Hyperfunction
- Cushing Syndrome
- Adrenal Gland Neoplasms