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Effect of Surgical or Conservative Approach in Patients With Adrenal Incidentalomas

NCT04860180 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-04-26

No results posted yet for this study

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

Interventions

PROCEDURE

adrenalectomy

Sponsors & Collaborators

  • Casa Sollievo della Sofferenza IRCCS

    collaborator OTHER

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    collaborator OTHER

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Iacopo Chiodini, Professor · Istituto Auxologico Italiano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-29
Primary Completion
2021-02-22
Completion
2022-12-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860180 on ClinicalTrials.gov