Adrenal Gland Diseases
Conditions
Interventions
Group 1: 16 patients with adrenal incidentaloma and with (possible) autonomous cortisol secretion will be submitted to laparoscopic adrenalectomy followed by intensive drug treatment of their possible
Group 2: 16 patients with suprarenal incidentaloma and with (possible) autonomous cortisol secretion will be followed with intensive drug treatment for their possible comorbidities
Group 3: 16 patients with nonfunctioning adrenal incidentaloma (cortisol levels post 1mg dexamethasone less than 1.8 mcg/dl) matched for sex, age, body mass index, abdominal circumference, systemic ar
Group 4: 16 healthy patients (absence of adrenal incidentaloma and cortisol levels post 1mg dexamethasone less than 1.8 mcg/dl), matched for gender, age, body mass index, waist circumference, systemic
Procedure/surgery
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Incor - Instituto do Coração do Hospital das Clínicas da FMUSP
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: All patients diagnosed with adrenal incidentaloma and characteristics suggestive of benignity in CT and/or MRI of the abdomen (homogeneous image, density 60%). Patients who meet these criteria will be invited to participate in the study, involving surgical treatment (laparoscopic adrenalectomy) of their adrenal incidentalomas and/or medication of their comorbidities. Patients with bilateral lesions will undergo adrenalectomy of the larger lesion
Exclusion criteria
Exclusion criteria: Patients with adrenal incidentaloma and diagnosis of pheochromocytoma, primary hyperaldosteronism, Cushing's syndrome overt, adrenal carcinoma or malignancies including extra adrenal metastases; high adrenocorticotropic hormone concentration; history of alcoholism; administration of drugs that may influence cortisol metabolism, dexamethasone or cortisol secretion; patients undergoing previous open abdominal surgery; chronic renal insufficiency or any contraindication for surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: to assess the role of adrenalectomy in adrenal incidentalomas with (possible) autonomous cortisol secretion in the normalization and/or improvement of blood pressure determined by normalization of blood pressure (less than 130x80 mmHg) without drug treatment; unchanged or decreased blood pressure in patients with hypertension if the number or dose of antihypertensive drugs has been reduced; unchanged normal blood pressure in normotensive patients at randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: comparing adrenalectomy and intensive drug treatment for cardiovascular risk factors: pulse wave velocity (PWV); carotid intima-media thickness (CIMT) verified by carotid doppler ultrasound; left ventricular hypertrophy (LVH) verified by echocardiography; visceral and subcutaneous fat using abdominal CT;Expected outcome 3: to evaluate the normalization and/or improvement of metabolic complications (diabetes mellitus, dyslipidemia, obesity) after adrenalectomy;Expected outcome 4: comparison of the two treatments in the improvement of quality of life by Cushing Qol. Questionnaire (Cushing Qol). For the psychopathological evaluation, the test of the Factorial Battery of Personality (FBP) will be used; mood screening by the Hospital Anxiety and Depression Scale (HADS); and self-evaluation of memory. In the neuropsychological evaluation, we will use the Rey Auditory-Verbal Learning Test (RAVLT) to assess cognitive impairment, memory and attention.;Expected outcome 5: comparison of the two strategies in direct costs related to their follow-up | — |
Countries
Brazil
Contacts
Public ContactMaria Barisson Villares Fragoso
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Outcome results
None listed