Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rare Cystic Benign Adrenal Incidentalomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739918
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdelbaset, Mansoura University

Brief Summary:
Benign complex cystic and vascular adrenal tumors comprise a group of lesions characterized by significant rarity. But, their detection is increasing due to improved radiologic imaging techniques. Nevertheless, they are still conflicting with other lesions. the investigators reviewed their experience with complex cystic benign adrenal tumors in adults, review previous reports to determine the appropriate diagnosis and management of these tumors.

Condition or disease
Urologic Diseases Adrenal Tumor

Detailed Description:

Adrenal masses are incidentally found on computed tomography (CT) of the abdomen (so-called "incidentaloma") (AIs) approximately 4% of the time and in 8% in autopsy series. It is important to distinguish benign from malignant. Also, differentiating functioning vs nonfunctioning tumors. The majority of AIs are nonfunctioning , benign lesions account for 82.5% of cases including adenomas (61%), myelolipomas (10%), adrenal cysts (6%), and ganglioneuromas (5.5%), cortisol-secreting adenomas (5.3%), pheochromocytomas (5.1%), adrenocortical carcinomas (4.7%), metastatic lesions (2.5%), and aldosteronomas (1%).

The frequency of adrenal incidentaloma reported in the radiology literature varies according to imaging modality with computed tomography (CT) scans and magnetic resonance imaging (MRI), it ranges from 0.3 to 7%, whereas with ultrasound, it is 0.4-2 %. The evaluation and classification of adrenal vascular tumors and cysts remain a challenging, in spite of, the frequency of detection over the past years has been facilitated by advances in imaging and molecular histopathology. This overlap not only because of their scarcity but because these lesions are often obscured by the extensive hemorrhage. As a result, surgical excision of these lesions has to trend in the last decades.

Because of that, we retrieved our data to determine the clinical features, histopathological pathognomonic features and the long term outcomes for these lesions.

The computerized dedicated database of patients who were treated for adrenal tumors between January 2010 and December 2017 was reviewed. Only patients aged >18 years were included in the study and their files were fully evaluated. The data collected were the age at the time of presentation, clinical features, medical history, adrenal metabolic profile, radiological tumor characteristics, treatment methods, and histopathological characteristics. In all cases, CT with contrast was performed unless contraindicated and MRI was performed. Also, basic hormonal assay including 24-hour urinary cortisol and plasma metanephrines were requested for all cases. Under general anesthesia with fixation of intra-arterial line, patients were explored laparoscopically or via the lumbar incision. Three days postoperative, the patient was discharged unless hormonal replacement therapy is required for a longer period of time. The patients were followed up by metabolic profile and radiologically after 6 and 12 months postoperatively then annually.


Layout table for study information
Study Type : Observational
Actual Enrollment : 291 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Complex Cystic Benign Adrenal Incidentalomas Mimicking Non-adenomatous Masses; Rare Pathologies: Clinical Features and Outcomes. Case Series With Short Review of Literature.
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : June 30, 2018


Group/Cohort
patients with adrenal masses
patients with adrenal mass managed by adrenalectomy



Primary Outcome Measures :
  1. Number of patients with rare pathologies and correlation with demographic and radiological data [ Time Frame: 7 years ]
    collection of rare pathologies ,correlation with other review of literature



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
291 cases diagnosed with adrenal tumors were treated. Demographic criteria of studied cases and different types of pathologies identified . Three cases were diagnosed to have rare cystic and vascular histopathological variant including: cavernous haemangioma, capillary haemangioma and adrenal teratoma.
Criteria

Inclusion Criteria:

  • cases with adrenal tumors above 18 years old with rare histopathology

Exclusion Criteria:

  • age less than 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739918


Locations
Layout table for location information
Egypt
Urology and Nephrology Center
Mansourah, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University

Layout table for additonal information
Responsible Party: Mohamed Abdelbaset, principal investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03739918     History of Changes
Other Study ID Numbers: adrenal incidentalomas
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Abdelbaset, Mansoura University:
Cystic
Adrenal
Incidentaloma
Vascular
Benign
Additional relevant MeSH terms:
Layout table for MeSH terms
Adrenal Gland Neoplasms
Adrenocortical Adenoma
Urologic Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases
Adrenal Cortex Neoplasms
Adrenal Cortex Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents