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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02543697
Acronym
AVS
Enrollment
30
Registered
2015-09-07
Start date
2015-02-28
Completion date
2020-02-29
Last updated
2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing Syndrome

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.

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.

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Use of steroids ( tablets, inhalations, lotions)

Design outcomes

Primary

MeasureTime frameDescription
Lateralisation of cortisol overproduction2 yerasIf the ratio between cortisol in the adrenal veins is over 3,3 , it is defined as unilateral overproduction of cortisol.

Secondary

MeasureTime frameDescription
Biochemically and clinically normalising after treatment2 yearsThe 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 adrenals2 yerasIf 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.

Countries

Norway

Contacts

Primary ContactGrethe Ueland, MD
geas@helse-bergen.no+4790950021
Backup ContactEystein Husebye, Prof.
eyhu@helse-bergen.no+4799404788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026