Clinical Trial: Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

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

Official Title: Randomized Control Trial of Adrenalectomy Versus Observation for Subclinical Hypercortisolism

Brief Summary:

Background:

- Adrenal tumors are a common kind of tumor. Some of these secrete extra cortisol into the body, which can lead to diabetes, obesity, and other diseases. Some people with extra cortisol will show symptoms like bruising and muscle weakness. Others will show no signs. This is called subclinical hypercortisolism. Some of these adrenal tumors become malignant. Researchers want to know the best way to treat people with subclinical hypercortisolism. They want to know if removing the tumor by surgery reduces the long-term effects of the disease.

Objectives:

- To see if removing an adrenal tumor by surgery improves blood pressure, diabetes, obesity, osteoporosis, or cholesterol, and cancer detection.

Eligibility:

- Adults 18 and older with an adrenal tumor and high cortisol levels.

Design:

  • Participants will be screened with medical history, blood tests, and a CT scan.
  • Participants will have a baseline visit. They will have blood and urine tests and 7 scans. For most scans, a substance is injected through a tube in the arm. Participants will lie still on a table in a machine that takes images.
  • Participants will have surgery to remove their tumor. Some will have surgery right away. Some will have surgery 6 months later, after 2 follow-up appointments.
  • Participants will have 4 follow-up visits in the first year after surgery. They will have 2 visits the second year, then yearly visits for 3 years. At each follow-up visit, they will have scans

    Detailed Summary:

    Background:

    • Adrenal incidentalomas are common and found in approximately 4-7% of the population.
    • About 0.6 to 25% of patients with an adrenal incidentaloma are found to have subclinical hypercortisolism: 2.3% develop subclinical hypercortisolism during follow up and 0.6% develop clinical hypercortisolism during follow up.
    • Subclinical hypercortisolism is defined as biochemical excess of cortisol without signs and symptoms of overt hypercortisolism but may be associated with metabolic complications or disease progression and malignancy.
    • Overt signs and symptoms of hypercortisolism include facial plethora, easy bruising, violaceous straiae, and proximal muscle weakness.
    • Several studies suggest that subclinical hypercortisolism may lead to long term consequences such as diabetes, hypertension, hypercholesterolemia, obesity, and osteoporosis.
    • Thus, patients with subclinical hypercortisolism may benefit from operative intervention to halt or reverse metabolic complications associated with the disease and the risk of malignant progression.
    • The optimal management of patients with subclinical hypercortisolism and adrenal incidentalomas is controversial and no large randomized trial has been conducted.
    • We hypothesize that operative treatment would reduce the risk of long term complications of subclinical hypercortisolism and malignant progression, and propose a prospective randomized trial comparing nonoperative and operative management of subclinical hypercortisolism in patients with an adrenal neoplasm.

    Objectives:

  • To determine the risk of primary adrenal malignancy in patients with subclinical hypercortisolism and adrenal mass less than 5 cm. [ Time Frame: 6 months ]
  • To determine whether FDG PET/CT scan is diagnostic of subclinical hypercortisolism. [ Time Frame: 6 months ]
  • To determine the optimal diagnostic test for subclinical hypercortisolism. [ Time Frame: 6 months ]
  • To determine whether patients show an improvement in quality of life after adrenalectomy compared to medical therapy. [ Time Frame: 6 months ]
  • To determine whether patients have an increased risk of deep venous thrombosis with subclinical hypercortisolism, regardless of treatment. [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: November 27, 2013
Date Started: November 19, 2013
Date Completion: July 1, 2019
Last Updated: May 12, 2017
Last Verified: January 24, 2017