Clinical trial · Interventional
Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas
NCT02364089CI-TRIAL-00068128CHIRACICcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Incidentalomas | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgical removal of the adrenal tumor | Procedure | — | UNRESOLVED |
| Standardized medical treatment of hypertension by SAHR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery followed by intensive medical care
- description
- Laparoscopic surgical removal of the adrenal tumor
- interventionNames
- Procedure: Laparoscopic surgical removal of the adrenal tumor
- type
- ACTIVE_COMPARATOR
- label
- Intensive medical treatment only
- description
- Standardized medical treatment of hypertension by SAHR.
- interventionNames
- Drug: Standardized medical treatment of hypertension by SAHR
Primary outcomes (1)
- measure
- Blood pressure value and SAHR step 12 months after inclusion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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, to be included, patients should need at least an extrastep of hypertensive treatment in order to allow the SAHR decrease following randomisation. The dose of betablocker has to stay the same during all the study.
* UFC \> ULN x 2.0 N,
* 8h00 plasma ACTH \> 20 pg/ml (4.4 pmol/L),
* Chronic renal insufficiency (clearance \< 30 mL/min)
* Dissipation of the biological endocrine criteria for SCSI at the end of the Run-In period,
* Intake of exogenous corticoids or drugs that interfere with dexamethasone metabolism,
* Pregnancy,
* Childbearing woman with no contraceptive effective method (HAS criteria - 77),
* Adverse pathological conditions responsible for reduced life expectancy.
Exclusion criteria after the Run-In period:
* Spontaneous resolution of biological features of SCSI
* Hypertension not confirmed with standard blood pressure self-measurement device
* Hypertension not controlled (≥ 135/85 mmHg) at the end of the Run-In period
* Malignant hypertension (\> 175/115 mmHg)
* Patient receiving betablocker and not receiving at least an extrastep of hypertensive treatment of the SAHRReferences
Publications (1)
- DERIVEDTabarin A, Espiard S, Deutschbein T, Amar L, Vezzossi D, Di Dalmazi G, Reznik Y, Young J, Desailloud R, Goichot B, Drui D, Assie G, Lefebvre H, Mai K, Castinetti F, Laboureau S, Terzolo M, Ferriere A, Georget A, Frison E, Vantyghem MC, Fassnacht M, Gosse P; CHIRACIC Collaborators. Surgery for the treatment of arterial hypertension in patients with unilateral adrenal incidentalomas and mild autonomous cortisol secretion (CHIRACIC): a multicentre, open-label, superiority randomised controlled trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):580-590. doi: 10.1016/S2213-8587(25)00062-2. Epub 2025 May 12. PMID 40373786