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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03739918
Other study ID # adrenal incidentalomas
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 28, 2018
Est. completion date June 30, 2018

Study information

Verified date November 2018
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 291
Est. completion date June 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- age less than 18 years

Study Design


Locations

Country Name City State
Egypt Urology and Nephrology Center Mansourah Aldakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with rare pathologies and correlation with demographic and radiological data collection of rare pathologies ,correlation with other review of literature 7 years
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