Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas (NCT02364089) | Clinical Trial Compass
CompletedNot Applicable
Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas
France78 participantsStarted 2015-04-09
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≤ 80 years.
* Unilateral SCSI:
* Incidentally discovered adrenal tumor with attenuation \< 20 UH and/or relative wash-out (\> 40%) or absolute wash-out (\> 60%) of contrast media and size ≥ 2 cm. Tumors that do not fulfil these criteria might be included if their size is ≤ 4 cm, do not exhibit signs of malignancy (necrosis areas, large and irregular rims) and are stable in size after ≥ 6 months of follow-up.
* Impaired 1 mg dexamethasone suppression (Cortisol \> 138 nmol/L or 5 µg/dL), OR Impaired 1 mg dexamethasone suppression (Cortisol \> 50 nmol/L or 1.8 µg/dL) AND one biochemical abnormalities among:
* 08h00 plasma ACTH \< 2.2 pmol/L or plasma ACTH following CRH injection ≤ 6.6 pmol/L,
* midnight plasma cortisol \> 150 nmol/L,
* increased late evening salivary cortisol,
* UFC between 1 and 2.0 x N.
* Treated BP (and confirmed using an automated home BP monitoring) OR increased BP (≥ 135/85 mmHg) none treated, using an automated home BP monitoring.
Exclusion Criteria:
* Age \> 80 y,
* Bilateral SCSI, Warning: Contralateral nodular formations \< 10 mm are considered as negligible,
* Incidentally discovered adrenal tumor size \< 2 cm,
* Malignant hypertension, stroke, pulmonary oedema or myocardial infarction during the previous year,
* Malignant hypertension during the Run-in period,
* Obligatory beta blocker treatment. Patients receiving betablocker treatment for other purpose than hypertension can be included. However, …
What they're measuring
1
Blood pressure value and SAHR step 12 months after inclusion