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

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ClinicalTrials.gov Identifier: NCT02543697
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Cushing Syndrome Radiation: Adrenal venous sampling

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  (Clinical Trial)
Estimated Enrollment : 30 participants
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


Arms and Interventions

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.


Outcome Measures

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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Use of steroids ( tablets, inhalations, lotions)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02543697


Contacts
Contact: Grethe Ueland, MD +4790950021 geas@helse-bergen.no
Contact: Eystein Husebye, Prof. +4799404788 eyhu@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Grethe Ueland, MD    +4790950021    geas@helse-bergen.no   
Contact: Hrafnkell Thordason, MD       hraf@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Grethe Ueland, MD Haukeland Univerity Hospital
More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02543697     History of Changes
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:
Cushing Syndrome
Syndrome
Adrenal Gland Neoplasms
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Epinephrine
Racepinephrine
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
Mydriatics
Sympathomimetics
Vasoconstrictor Agents