Clinical Trial: Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas

Brief 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.

Detailed Summary:

Adrenal incidentalomas are unsuspected adrenal masses found during abdominal imaging. With the widespread use of computed tomography and MRI, adrenal incidentalomas are found in approximately 2% of patients. In an endocrinology setting, the majority of these masses are benign adenomas of the adrenal cortex. Approximately 10% of these adenomas display little excess of cortisol secretion associated to some degree of secretory autonomy but that are insufficient to generate overt Cushing's syndrome ("Subclinical Secreting Cortisol incidentalomas" or SCSI). However, hypertension and to a lesser degree obesity and impaired glucose tolerance are very frequent amongst patients with SCSI. The hypothesis that the mild hypercortisolism associated with SCSI is responsible for these clinical consequences is substantiated by few studies describing improvement after resection of SCSI. However, these studies were retrospective, uncontrolled and suffered from imprecision and numerous methodological bias. Thus, whether surgery is more beneficial than medical treatment is currently unknown and there is no consensus on the appropriate treatment for SCSI.

Patient selection Run-In period. Discontinuation of previous antihypertensive treatments and prescription of a standardized anti-hypertensive drug regimen (SAHR). Monthly Blood Pressure (BP) measurement using home BP monitoring. The duration of the Run-In periods will be ≤ 6 months and will end when BP will be controlled with the SAHR at two consecutive visits.

End of RI Second endocrine assessment for eligibility Randomization (Ra): 24h Ambulatory BP measurement, anthropometric and metabolic evaluation. Quality of life and cognition questionnaires. Randomization in 2 groups : Gr 1 Treatment group : Surgery followed by intensive medical care ; Gr 2 : Control Group : intensive
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Blood pressure value and SAHR step 12 months after inclusion [ Time Frame: 12 months ]

Treatment response will defined as a reduction of at least 1 step of SAHR at the end of the study, with BP maintained within the study objectives (125-135 mm Hg systolic and 75-85 mm Hg diastolic) according to self-measurement at home.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Antihypertensive treatment score and daily drug dose [ Time Frame: 12 months ]
  • Incidence of complications in the two strategies. [ Time Frame: 12 months ]
  • Direct costs of the two strategies. [ Time Frame: 12 months ]
  • Assessment of predictive factors for the success of surgery on BP [ Time Frame: 12 months ]
    age, family history of hypertension, duration of hypertension, kidney function, biochemical endocrine abnormalities, urinary steroid profile
  • number of patients requiring antihypertensive treatment [ Time Frame: 12 months ]
  • 24 hours ambulatory blood pressure monitoring values [ Time Frame: At inclusion (day 0) and at 12 months ]
  • Blood glucose and lipid lowering agents values [ Time Frame: 12 months ]
  • Cardiovascular risk factors/markers level [ Time Frame: 12 months ]
    Comparison of the two therapeutic strategies with regard to cardiovascular risk factors/markers: BMI, body composition evaluated by DEXA, abdominal fat evaluated on CT-scan, fasting blood glucose and insulin, HbA1C, HOMA-IR (homeostasis model of assessment of insulin resistance) and OGTT (oral glucose tolerance test), blood lipids, pro-inflammatory adipokines
  • Number of patients with persistent diabetes, dyslipidemia and metabolic syndrome [ Time Frame: 12 months ]
  • Evaluation of quality of life [ Time Frame: At inclusion and 12 months ]
    Comparison of the two therapeutic strategies with regard to quality of life


Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: January 28, 2015
Date Started: January 2015
Date Completion: September 2018
Last Updated: February 13, 2015
Last Verified: February 2015