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
|Condition or disease||Intervention/treatment||Phase|
|Cushing Syndrome||Radiation: Adrenal venous sampling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Grethe Ueland, MDfirstname.lastname@example.org|
|Contact: Eystein Husebye, Prof.||+email@example.com|
|Haukeland University Hospital||Recruiting|
|Bergen, Norway, 5021|
|Contact: Grethe Ueland, MD +4790950021 firstname.lastname@example.org|
|Contact: Hrafnkell Thordason, MD email@example.com|
|Principal Investigator:||Grethe Ueland, MD||Haukeland Univerity Hospital|