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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Haukeland University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Biochemically and clinically normalising after treatment [ Time Frame: 2 years ]
    The patients will be offered operation if the overproduction seems to be unilateral. They will then be evaluated for cortisol abnormalities , blood sugar, and hypertension i intervals of 6 months after surgery ,to see if the parameters improve. They who are not operated will be evaluated in the same way.
  • Verify overproduction of cortisol from the adrenals [ Time Frame: 2 yeras ]
    If the ratio between cortisol in the adrenal vein and the periphery vein is over 3,3 it is defined as overproduction, and if it is over 6,5 it will probably be an adenoma.


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: February 13, 2015
Date Started: February 2015
Date Completion: February 2020
Last Updated: September 7, 2016
Last Verified: September 2016