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Adrenalectomy Versus Follow-up in Patients With Mild Hypercortisolism: a Prospective Randomized Controlled Trial


N/A
18 Years
N/A
Open (Enrolling)
Both
Adrenal Tumour With Mild Hypercortisolism

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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

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