Clinical trial · Interventional
Study of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
Randomized Control Trial of Adrenalectomy Versus Observation for Subclinical Hypercortisolism
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was closed due to low accrual.
Summary
Brief summary (as posted)
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 computed tomography (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 and blood tests.
Conditions
Conditions (3)
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 Neoplasm | Adrenal Gland Neoplasm | ALIAS | 0.90 |
| Cushing Syndrome | — | UNRESOLVED | — |
| Subclinical Hypercortisolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adrenalectomy | Procedure | — | UNRESOLVED |
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Operative Arm
- description
- operative arm
- interventionNames
- Procedure: Adrenalectomy
- type
- OTHER
- label
- Delayed Operative Arm
- description
- delayed operative arm
- interventionNames
- Other: Observation
Primary outcomes (2)
- measure
- Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy
- timeFrame
- Assessed at 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * An individual with an adrenal neoplasm less than 5 cm in size with biochemically confirmed evidence of hypercortisolism (2 out of 3: dexamethasone suppression test (DST) \>3 mcgl/dL, elevated urine free cortisol, and/or morning adrenocorticotropic hormone (ACTH) \<2.2 pmol/l) without overt clinical signs and symptoms. * Age greater than or equal to 18 years. * Adults must be able to understand and sign the informed consent document. * Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice. EXCLUSION CRITERIA: * Biochemically and/or radiologically confirmed pheochromocytoma, hyperaldosteronism, or adrenocortical carcinoma. * Nonfunctioning adrenal neoplasm. * Pre-existing cancers and/or metastatic disease to the adrenal glands. * Pregnancy and/or lactation. * Lack of metabolic complications. * Imaging features worrisome for malignancy (heterogeneous tumor, presence of calcifications, necrosis, \>10 Hounsfield units on an unenhanced computed tomography (CT) scan, and delayed washout of contrast).
References
Publications (4)
- BACKGROUNDToniato A, Merante-Boschin I, Opocher G, Pelizzo MR, Schiavi F, Ballotta E. Surgical versus conservative management for subclinical Cushing syndrome in adrenal incidentalomas: a prospective randomized study. Ann Surg. 2009 Mar;249(3):388-91. doi: 10.1097/SLA.0b013e31819a47d2. PMID 19247023
- BACKGROUNDReincke M. Subclinical Cushing's syndrome. Endocrinol Metab Clin North Am. 2000 Mar;29(1):43-56. doi: 10.1016/s0889-8529(05)70115-8. PMID 10732263
- BACKGROUNDChiodini I. Clinical review: Diagnosis and treatment of subclinical hypercortisolism. J Clin Endocrinol Metab. 2011 May;96(5):1223-36. doi: 10.1210/jc.2010-2722. Epub 2011 Mar 2. PMID 21367932
- DERIVEDNeychev V, Steinberg SM, Yang L, Mehta A, Nilubol N, Keil MF, Nieman L, Stratakis CA, Kebebew E. Long-Term Outcome of Bilateral Laparoscopic Adrenalectomy Measured by Disease-Specific Questionnaire in a Unique Group of Patients with Cushing's Syndrome. Ann Surg Oncol. 2015 Dec;22 Suppl 3(Suppl 3):S699-706. doi: 10.1245/s10434-015-4605-1. Epub 2015 May 13. PMID 25968622