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

Primary Purpose

Cushing Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Adrenal venous sampling
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cushing Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Use of steroids ( tablets, inhalations, lotions)

Sites / Locations

  • Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adrenal venous sampling

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 13, 2015
Last Updated
September 7, 2016
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02543697
Brief Title
Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
Acronym
AVS
Official Title
Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adrenal venous sampling
Arm Type
Experimental
Arm Description
Patients going trough an adrenal venous sampling to find out if hypercortisolism is uni or bilaterally produced.
Intervention Type
Radiation
Intervention Name(s)
Adrenal venous sampling
Intervention Description
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 Measure Information:
Title
Lateralisation of cortisol overproduction
Description
If the ratio between cortisol in the adrenal veins is over 3,3 , it is defined as unilateral overproduction of cortisol.
Time Frame
2 yeras
Secondary Outcome Measure Information:
Title
Biochemically and clinically normalising after treatment
Description
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.
Time Frame
2 years
Title
Verify overproduction of cortisol from the adrenals
Description
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.
Time Frame
2 yeras

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol Exclusion Criteria: Use of steroids ( tablets, inhalations, lotions)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grethe Ueland, MD
Phone
+4790950021
Email
geas@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Eystein Husebye, Prof.
Phone
+4799404788
Email
eyhu@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grethe Ueland, MD
Organizational Affiliation
Haukeland Univerity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grethe Ueland, MD
Phone
+4790950021
Email
geas@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Hrafnkell Thordason, MD
Email
hraf@helse-bergen.no

12. IPD Sharing Statement

Citations:
PubMed Identifier
30137397
Citation
Ueland GA, Methlie P, Jossang DE, Sagen JV, Viste K, Thordarson HB, Heie A, Grytaas M, Lovas K, Biermann M, Husebye ES. Adrenal Venous Sampling for Assessment of Autonomous Cortisol Secretion. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4553-4560. doi: 10.1210/jc.2018-01198.
Results Reference
derived

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

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