Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
AVS
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 13, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedSeptember 8, 2016
September 1, 2016
4 years
February 13, 2015
September 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Biochemically and clinically normalising after treatment
2 years
Verify overproduction of cortisol from the adrenals
2 yeras
Study Arms (1)
Adrenal venous sampling
EXPERIMENTALPatients going trough an adrenal venous sampling to find out if hypercortisolism is uni or bilaterally produced.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol
You may not qualify if:
- Use of steroids ( tablets, inhalations, lotions)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haukeland University Hospital
Bergen, 5021, Norway
Related Publications (1)
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.
PMID: 30137397DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grethe Ueland, MD
Haukeland Univerity Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2015
First Posted
September 7, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2019
Study Completion
February 1, 2020
Last Updated
September 8, 2016
Record last verified: 2016-09