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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02543697
Recruitment Status : Unknown
Verified September 2016 by Haukeland University Hospital.
Recruitment status was:  Recruiting
First Posted : September 7, 2015
Last Update Posted : September 8, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cushing Syndrome Radiation: Adrenal venous sampling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
Study Start Date : February 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Adrenal venous sampling
Patients going trough an adrenal venous sampling to find out if hypercortisolism is uni or bilaterally produced.
Radiation: Adrenal venous sampling
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02543697

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Contact: Grethe Ueland, MD +4790950021
Contact: Eystein Husebye, Prof. +4799404788

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Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Grethe Ueland, MD    +4790950021   
Contact: Hrafnkell Thordason, MD   
Sponsors and Collaborators
Haukeland University Hospital
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Principal Investigator: Grethe Ueland, MD Haukeland Univerity Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Haukeland University Hospital Identifier: NCT02543697    
Other Study ID Numbers: 2014/2170
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Adrenal Gland Neoplasms
Cushing Syndrome
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents