Effect of Surgical or Conservative Approach in Patients With Adrenal Incidentalomas

NCT04860180 | Unknown

• 1 other identifier: RF-2013-02356606
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subclinical hypercortisolism (SH) is a status of asymptomatic hypercortisolism, frequently found in patients with adrenal adenomas (estimated prevalence: 0.8-2% after 60 years of age). Although SH may lead to diabetes, hypertension and osteoporosis, the diagnostic SH criteria and those suggesting the need of adrenalectomy are debated. Indeed, beside the cortisol secretion, the individual cortisol sensitivity may play a role in determining the SH consequences. Subjects with possible SH due to adrenal adenoma will be randomized to surgery/conservative follow up. The effects of surgery on the cardiovascular, bone, metabolic complications of SH and on neuropsychological aspects and quality of life (QoL) and the possibility to predict them by using cortisol sensitivity and secretion markers will be studied. The study may clarify how to individuate patients who can benefit from surgery. These results will help reducing the costs of both useless surgical operations and SH consequences.

Conditions

Adrenal Incidentaloma; Subclinical Hypercortisolism

Outcome Measures

Primary Outcomes (10)

• variation of blood pressure

  To assess the variation of blood pressure ambulatory systolic and diastolic blood pressure (BP, mmHg), and antihypertensive treatment at baseline and follow-up will be assessed; BP will be considered improved or worsened if the non-hypertensive patients passed from a pre-hypertension category to another or the hypertensive patients from a hypertension grade to another in accordance to giudelines, of if if antihypertensive treatment was reduced by 50%

  6 months

• variation of glucose levels

  To assess the variation of glucose levels, fasting glucose levels and glucose levels after oral glucose tolerance test will be evaluated at baseline and follow-up. Glucose levels will be considered improved or worsened if fasting glucose levels pass from a category to another, following the Adult Treatment Panel III criteria or if antidiabetic treatment was reduced by 50%

  6 months

• variation of lipids

  At baseline and follow up triglyceride levels; total cholesterol levels, HDL and LDL levels (mg/dl) will be evaluated. Dyslipidemia will be diagnosed in the presence of triglyceride levels \>150 mg/dl or high-density lipoprotein (HDL) cholesterol levels \<40 or 50 mg/dl in males and females. dyslipidemia will be defined improved or worsened if cholesterol levels pass from a category to another, following the Adult Treatment Panel III criteria

  6 months

• variation of body weight

  At baseline and follow up body weight (kilograms) will be evaluated. the improvement/worsening during follow-up will be defined in the presence of a \>5% BW decrease/increase

  6 months

• variation of bone mineral density (BMD)

  To assess the variation of bone mineral density at baseline and follow-up a Dual-energy X-ray absorptiometry (DXA) scan will be performed

  24 months

• occurrence of vertebral fractures

  A dorso-lumbar spine x-ray to evaluate the presence of morphometric fractures (presence/absence) will be performed

  24 months

• variation of intimal medial thickness

  To assess the variation of vascular damage a supra-aortic trunk echo-Doppler to evaluate at baseline and follow-up variations of intimal medial thickness will be performed

  12 months

• variation of Relative wall thickness (RWT)

  the variation of Relative wall thickness (RWT) will be evaluated by an echocardiography. It will be calculated from Left ventricular end diastolic dimension (LVEDD) (mm); Interventricular septal end diastole (IV Sd, mm) and Posterior wall thickness at end-diastole (PWd) parameters (mm)

  12 months

• variation of Sheehan Disability Scale

  Sheehan Disability Scale will be evaluated to assess perceived stress (SDS-stress scale ranges 1-10, a higher score means higher levels of stress)

  6 months

• Cognitive evaluation by Brief Assessment Cognition in Schizophrenia (BACS) score

  BACS evaluate verbal memory score (normal if \>33); working memory (normal if \>14.9); verbal fluency (normal if \>31.6), symbol coding (normal if \>40.5), tower of london (\>12.4)

  6 months

Secondary Outcomes (2)

• cortisol secretion and sensitivity

  24 months

• variation of Inflammation markers and bone metabolism markers

  6 months

Study Arms (2)

A, surgery

EXPERIMENTAL

adrenalectomy

Procedure: adrenalectomy

B, observation

NO INTERVENTION

conservative follow up

Interventions

adrenalectomy PROCEDURE

A, surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral adrenal incidentaloma larger than 1 cm
• cortisol after 1-mg overnight dexamethasone suppression test (1mgDST) between 1.8 and 5 mcg/dl

You may not qualify if:

• hypogonadism, thyrotoxicosis, chronic renal failure and hepatic disease, alcoholism, eating, rheumatologic or hematological disorders;
• intake of drugs influencing cortisol and dexamethasone metabolism or cortisol secretion;
• signs of hypercortisolism (moon facies, striae rubrae, easy bruising);
• possible metastatic disease or radiologic features not consistent with adrenocortical adenoma at computed tomography (CT);
• pheochromocytoma and aldosteronoma;
• non-adrenal SH.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• Casa Sollievo della Sofferenza IRCCS: collaborator
• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: collaborator
• Ministry of Health, Italy: collaborator

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MeSH Terms

Conditions

Adrenal incidentaloma

Interventions

Adrenalectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Iacopo Chiodini, Professor

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endocrinology, MD

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: April 26, 2021
• Study Start: September 29, 2016
• Primary Completion: February 22, 2021
• Study Completion: December 8, 2022
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share