Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas

• Status: Active, not recruiting
• Trial end date: 2022-11-09
• Target enrollment: 0
• Participant gender: All

Summary

The general objective is to evaluate the consequences of surgical removal of SCSI on hypertension and cardiovascular risk factors in order to determine on an evidence-based basis if surgical excision of SCSI is preferable to an intensive medical regimen in patients with hypertension.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Epinephrine; Epinephryl borate; Hydrocortisone; Racepinephrine

Criteria

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 µg/dL)

OR

• Impaired DST (cortisol > 50 83 nmol/L or 1,8 3 µg/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 µg/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