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

Cushing Syndrome Clinical Trial

— AVS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02543697
• Other study ID #: 2014/2170
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2015
• Last updated: September 7, 2016
• Start date: February 2015
• Est. completion date: February 2020

Study information

• Verified date: September 2016
• Source: Haukeland University Hospital
• Contact: Grethe Ueland, MD
• Phone: +4790950021
• Email: geas[@]helse-bergen.no
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Use of steroids ( tablets, inhalations, lotions)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Cushing Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	2 years	No
Secondary	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.	2 yeras	No