Adrenal TumorNCT06330558
Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma.
An observational study of Adrenal Tumor, run by Zagazig University.
Trial summary
Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Tumor
- What is being tested?
- laparoscopic right adrenalectomy
- Type of treatment
- Surgery or procedure
- How many people
- 271 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: An analysis of individuals who have undergone TLA and have unilateral PHEO of any size, aged over 18 years, and of both sexes.
Who may be able to join
- Unilateral pheochromocytoma of any size, over 18 years old, both males and females
Who cannot join
- Patients undergoing initial open adrenalectomy, - Additional surgical interventions during total laparoscopic adrenalectomy, - Partial adrenalectomy,
- Bilateral PHEOS. Hemorrhagic diathesis, Structural deformity Pregnancy,
- Prior unilateral abdominal surgery, data is absent. The preoperative diagnosis is ambiguous. Hereditary (PHEO), or recurrent PHEO
About this study
Official title: Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma. A Comparative Analysis
Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).
Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.
Read the detailed description
The process of performing an adrenalectomy for pheochromocytoma (PHEO) is difficult due to the significant risk of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).
Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.
- Conditions
- Adrenal Tumor
- Being tested
- laparoscopic right adrenalectomy
- Medical subject headings
- Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic right adrenalectomyProcedure or surgery
adrenalectomy
| Study group | Role | What they receive |
|---|---|---|
| group A | laparoscopic right adrenalectomy Receives: Procedure: laparoscopic right adrenalectomy | |
| Group B | laparoscopic left adrenalectomy Receives: Procedure: laparoscopic right adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion
number of conversion
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Sep 2016
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal TumorStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330558
- Sponsor's protocol ID
- pheos
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma. A Comparative Analysis
- ClinicalTrials.gov ID
- NCT06330558
- Acronym / sponsor ID
- pheos
- Conditions
- Adrenal Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 26 Mar 2024 (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.
Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).
Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.
Detailed description
The process of performing an adrenalectomy for pheochromocytoma (PHEO) is difficult due to the significant risk of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).
Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Procedure: laparoscopic right adrenalectomylaparoscopic right adrenalectomy |
| Group B | – | Procedure: laparoscopic right adrenalectomylaparoscopic left adrenalectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An analysis of individuals who have undergone TLA and have unilateral PHEO of any size, aged over 18 years, and of both sexes.
Key inclusion criteria (1 listed)
- Unilateral pheochromocytoma of any size, over 18 years old, both males and females
Key exclusion criteria (3 listed)
- Patients undergoing initial open adrenalectomy, - Additional surgical interventions during total laparoscopic adrenalectomy, - Partial adrenalectomy,
- Bilateral PHEOS. Hemorrhagic diathesis, Structural deformity Pregnancy,
- Prior unilateral abdominal surgery, data is absent. The preoperative diagnosis is ambiguous. Hereditary (PHEO), or recurrent PHEO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic right adrenalectomyadrenalectomy | Procedure or surgery | Group B, group A |
Primary outcome
conversion
Time frame: intraoperative
number of conversion
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 28 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Tumor, run by Zagazig University.
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 3 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
conversion (time frame: intraoperative). 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 28 Mar 2024.