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Clinical Trials/NCT02543697
NCT02543697UnknownNot Applicable

Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors

Haukeland University Hospital2 sites in 1 country30 target enrollmentStarted: February 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Lateralisation of cortisol overproduction

Study Overview

Brief Summary

Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify if the overproduction of cortisol is from one adrenal, or from both sides. If it is one-sided, the investigators offer the patient operation.

Detailed Description

Adrenal incidentalomas are quite common. About 4 % of the population have adrenal tumors that they are unknown of. Some percentage of this patients produce a little to much cortisol, but not enough to give overt Cushings syndrome. It is shown that slightly elevated cortisol production will give higher blood pressure, higher blood sugar and maybe higher BMI. For another hormone produced in the adrenal glands , aldosterone, we know that even if you have an adrenal tumor on one adrenal, you could have bilateral overproduction of the hormone.In that situations it is no need of an operation of the adrenal with the tumor. When the overproduction is unilateral it is of great value to the patient to operate the adrenal gland, and the symptoms from the hormone excess will disappear. For aldosterone Adrenal venous sampling (AVS) has been used for several years to try to determine if the hormone overproduction is one-sided or to sided. We are in this study using the same principle for cortisol overproduction.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol

Exclusion Criteria

  • Use of steroids ( tablets, inhalations, lotions)

Outcomes

Primary Outcomes

Lateralisation of cortisol overproduction

Time Frame: 2 yeras

If the ratio between cortisol in the adrenal veins is over 3,3 , it is defined as unilateral overproduction of cortisol.

Secondary Outcomes

  • Biochemically and clinically normalising after treatment(2 years)
  • Verify overproduction of cortisol from the adrenals(2 yeras)

Investigators

Sponsor
Haukeland University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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