Last updated on October 2018

Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Adrenal Incidentalomas
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 80 years.
  • Incidentally discovered unilateral SCSI:
  • Adrenocortical tumor on CT (spontaneous density < 20 HU and/or relative wash-out > 40%, absolute wash-out > 60% ) and > 2 cm in size.
  • Impaired DST (cortisol > 138 nmol/L or 5 g/dL)

OR

Impaired DST (cortisol > 50 83 nmol/L or 1,8 3 g/dL) AND one biological abnormality of the corticotropic axis at study entry:

  • 8 a.m. plasma ACTH < 2.2 pmol/L (10 pg/ml),
  • In case of ACTH at 8 a.m. between 10 and 20 pg/mL (2.2 and 4.4 pmol/L), peak of ACTH < 30 pg/mL (6.6 pmol/L) after a CRH test
  • midnight cortisol > 150 nmol/L (5.4 g/dL)
  • elevated late-evening salivary cortisol according to the range of the assay
  • increased 24-hour free urinary cortisol but <2.0-fold the laboratory upper normal limit.
  • Systolic or diastolic hypertension treated

OR

  • Systolic or diastolic hypertension (> 135/85 mmHg) not treated assessed on standard blood pressure self-measurement device.
  • Written informed consent signed by patient and investigator

Exclusion Criteria:

  • Age > 80 years.
  • Bilateral incidentaloma.
  • Incidentally adrenocortical tumor < 2 cm
  • History of myocardial infarction, pulmonary edema or stroke during the previous year
  • Malignant hypertension (> 175-115 mm Hg on self-measurement)
  • Beta-blocker treatment that cannot be suspended.
  • Free urinary cortisol > 2.0-fold upper normal limit
  • 08h00 plasma ACTH concentration > 4.4 pmol/L (20 pg/ml)
  • Chronic renal insufficiency (clearance < 30 mL/min)
  • Exogenous corticosteroid treatment by general or local route (inhaled, eye or ear drops , ophthalmic ointment, topical skin application, ear infiltration) during the 6 months before the trial

OR

Need for Corticosteroid treatment

OR

Medication interfering with dexamethasone metabolism.(54)

  • Pregnancy
  • Life-threatening pathology (in the short term)
  • Contra-indications to surgery
  • Lack of control of blood pressure at the end of the Run-In period
  • Dissipation of the biological endocrine criteria for SCSI at the end of the Run-In period

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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