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

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.

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

Conditions
-----------------
Cushing Syndrome

Intervention / Treatment
-----------------
* Radiation: Adrenal venous sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol Exclusion Criteria: Use of steroids ( tablets, inhalations, lotions)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adrenal venous sampling<br>Patients going trough an adrenal venous sampling to find out if hypercortisolism is uni or bilaterally produced. | Radiation: Adrenal venous sampling<br>* We go trough the femoral vein with a catheter up to the adrenal vein first on the left side, then on the right side. We take blood samples and analyze cortisol, metanefrin/ normetanefrin, aldosterone both from the adrenal veins and from the peripher vein. Then we use criteria from the Majo clinic to identify if the overproduction of cortisol is uni- or bilateral.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lateralisation of cortisol overproduction | If the ratio between cortisol in the adrenal veins is over 3,3 , it is defined as unilateral overproduction of cortisol. | 2 yeras | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically and clinically normalising after treatment | 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. | 2 years | 
| Verify overproduction of cortisol from the adrenals | 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. | 2 yeras |