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

Not Applicable

• Conditions: Cushing Syndrome
• Interventions: Radiation: Adrenal venous sampling

• Registration Number: NCT02543697
• Lead Sponsor: Haukeland University Hospital

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08
• Primary Completion: 2019-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Use of steroids ( tablets, inhalations, lotions)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adrenal venous sampling	Adrenal venous sampling	Patients going trough an adrenal venous sampling to find out if hypercortisolism is uni or bilaterally produced.

Primary Outcome Measures

Name	Time	Method
Lateralisation of cortisol overproduction	2 yeras	If the ratio between cortisol in the adrenal veins is over 3,3 , it is defined as unilateral overproduction of cortisol.

Secondary Outcome Measures

Name	Time	Method
Biochemically and clinically normalising after treatment	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	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.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway