Urologic DiseasesNCT03739918
Rare Cystic Benign Adrenal Incidentalomas
An observational study of Urologic Diseases and Adrenal Tumor, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Adrenal Tumor
- How many people
- 291 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2018to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- cases with adrenal tumors above 18 years old with rare histopathology
Who cannot join
- age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complex Cystic Benign Adrenal Incidentalomas Mimicking Non-adenomatous Masses; Rare Pathologies: Clinical Features and Outcomes. Case Series With Short Review of Literature.
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.
Read the 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.
- Conditions
- Urologic Diseases, Adrenal Tumor
- Keywords
- Cystic, Adrenal, Incidentaloma, Vascular, Benign
- Medical subject headings
- Urologic Diseases, Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with adrenal masses | patients with adrenal mass managed by adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with rare pathologies and correlation with demographic and radiological data
collection of rare pathologies ,correlation with other review of literature
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start28 Feb 2018
- Primary completion30 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelbaset, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739918
- Sponsor's protocol ID
- adrenal incidentalomas
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Cystic Benign Adrenal Incidentalomas Mimicking Non-adenomatous Masses; Rare Pathologies: Clinical Features and Outcomes. Case Series With Short Review of Literature.
- ClinicalTrials.gov ID
- NCT03739918
- Acronym / sponsor ID
- adrenal incidentalomas
- Conditions
- Urologic Diseases, Adrenal Tumor
- Keywords
- Cystic, Adrenal, Incidentaloma, Vascular, Benign
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with adrenal masses | – | –patients with adrenal mass managed by adrenalectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- cases with adrenal tumors above 18 years old with rare histopathology
Key exclusion criteria (1 listed)
- age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases and Adrenal Tumor, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with rare pathologies and correlation with demographic and radiological data (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.