Adrenal MyelolipomaNCT06913842
Adrenal Myelolipomas Case Series
An observational study of Adrenal Myelolipoma, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Six cases (72 years old female patient, 63 years old male patient, 57 years old female patient, 61 years old female, 72 years old female and 56 years old female) of clinically and radiologically suspected cases of symptomatic adrenal myelolipoma are discussed here. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adrenal Myelolipoma
- How many people
- 6 participants
- Where
- 1 siteMexico
- Study dates
- 28 Feb 2024to 25 Dec 2024
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 6 Patients who underwent laparoscopic surgery.
Who may be able to join
- Patients with adrenal myelolipoma
Who cannot join
- Patients without CT scan with myelolipoma
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Mexican Social Security Institute: Regional General Hospital No. 1
Mérida, Yucatán, 97000
About this study
Official title: Adrenal Myelolipomas Case Series Laparoscopic Management
Six cases (72 years old female patient, 63 years old male patient, 57 years old female patient, 61 years old female, 72 years old female and 56 years old female) of clinically and radiologically suspected cases of symptomatic adrenal myelolipoma are discussed here. All cases described, presented with flank pain radiating which was suspected as adrenal mass by Computed Tomography (CT) evaluation. All six cases were histopathologically confirmed as adrenal myelolipoma and managed by laparoscopic surgical excision.
Read the detailed description
The management in all cases was by laparoscopic adrenalectomy with transperitoneal approach. Several retrospective and comparative studies addressed the advantage of minimally invasive adrenalectomy specifically consistent in less postoperative pain, improved patients' satisfaction, shorter hospital stay and recovery time when compared to open adrenalectomy.
The laparoscopic transabdominal lateral adrenalectomy is currently the most widely used approach.
All our cases were managed by this technique. In our cases initial peritoneal access is achieved 2cm inferior to the right/left costal margin in the midclavicular line, a pressure of 15mmHg is used for CO2 insufflation. Optical access 10-12mm trocar for the endoscope is placed in the pararectal line 5cm above the umbilicus. Under direct vision, the second 10- 12 mm trocar is placed medially to the first one. The third trocar (5mm) is inserted 3 cm above the anterior superior iliac spine in the anterior axillary line. The fourth trocar (5mm) is inserted at the subcostal angle. The key factor for an adequate exposure is an effective dissection of the Toldt fascia. Vascular structures are ligated with Hem-O-Lock and subsequent dissection of the adrenal gland with ultrasonic energy. The adrenal is extracted through a Gibson-type incision, a Penrose drain was left in all cases with its removal upon discharge of the patient.
- Conditions
- Adrenal Myelolipoma
- Keywords
- Adrenal, Incidentaloma, Myelolipoma, Laparoscopy.
- Medical subject headings
- Myelolipoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality in surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start28 Feb 2024
- Primary completion20 Oct 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal MyelolipomaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Huber Díaz Fuentes, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913842
- Sponsor's protocol ID
- 98235522
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anyone who ask via E-mail.
Publications
Samimagham H, Kazemi Jahromi M. Bilateral Adrenal Myelolipoma, A Case Presentation and Brief Literature Review. Iran J Kidney Dis. 2020 Jan;14(1):62-64.
PubMed 32156843
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Myelolipomas Case Series Laparoscopic Management
- ClinicalTrials.gov ID
- NCT06913842
- Acronym / sponsor ID
- 98235522
- Conditions
- Adrenal Myelolipoma
- Keywords
- Adrenal, Incidentaloma, Myelolipoma, Laparoscopy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 6 Apr 2025 (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.
Six cases (72 years old female patient, 63 years old male patient, 57 years old female patient, 61 years old female, 72 years old female and 56 years old female) of clinically and radiologically suspected cases of symptomatic adrenal myelolipoma are discussed here. All cases described, presented with flank pain radiating which was suspected as adrenal mass by Computed Tomography (CT) evaluation. All six cases were histopathologically confirmed as adrenal myelolipoma and managed by laparoscopic surgical excision.
Detailed description
The management in all cases was by laparoscopic adrenalectomy with transperitoneal approach. Several retrospective and comparative studies addressed the advantage of minimally invasive adrenalectomy specifically consistent in less postoperative pain, improved patients' satisfaction, shorter hospital stay and recovery time when compared to open adrenalectomy.
The laparoscopic transabdominal lateral adrenalectomy is currently the most widely used approach.
All our cases were managed by this technique. In our cases initial peritoneal access is achieved 2cm inferior to the right/left costal margin in the midclavicular line, a pressure of 15mmHg is used for CO2 insufflation. Optical access 10-12mm trocar for the endoscope is placed in the pararectal line 5cm above the umbilicus. Under direct vision, the second 10- 12 mm trocar is placed medially to the first one. The third trocar (5mm) is inserted 3 cm above the anterior superior iliac spine in the anterior axillary line. The fourth trocar (5mm) is inserted at the subcostal angle. The key factor for an adequate exposure is an effective dissection of the Toldt fascia. Vascular structures are ligated with Hem-O-Lock and subsequent dissection of the adrenal gland with ultrasonic energy. The adrenal is extracted through a Gibson-type incision, a Penrose drain was left in all cases with its removal upon discharge of the patient.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 6 Patients who underwent laparoscopic surgery.
Key inclusion criteria (1 listed)
- Patients with adrenal myelolipoma
Key exclusion criteria (1 listed)
- Patients without CT scan with myelolipoma
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
Mortality
Time frame: 6 months
Mortality in surgery.
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 6 Apr 2025.
- Results publication: PubMed 32156843Samimagham H, Kazemi Jahromi M. Bilateral Adrenal Myelolipoma, A Case Presentation and Brief Literature Review. Iran J Kidney Dis. 2020 Jan;14(1):62-64.
- Individual participant dataSharing planned: Yes. Anyone who ask via E-mail.
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 Adrenal Myelolipoma, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 6 Apr 2025. 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 Mexico. 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?
Mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06913842, which also lists 1 linked publication.
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 6 Apr 2025.