Arterial Splenic AneurysmNCT04502147
How to Provide Vascular Control of Splenic Artery Aneurysm? Report of Two Cases
An observational study of Arterial Splenic Aneurysm, run by Tecnologico de Monterrey at 1 site in Mexico.
Trial summary
Spleen artery aneurysm represents the most common visceral aneurysm and the third most common splanchnic aneurysm. Most patients have no symptoms and are diagnosed as a part of other diagnostic focuses and examinations. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Arterial Splenic Aneurysm
- What is being tested?
- Laparoscopic Splenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2020to 30 Jul 2020
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 41-year-old patient who was diagnosed with splenic artery enlargement on a routine ultrasound examination.
Who may be able to join
- Adults patients (>18 year old) with splenic arterial aneurysms
Who cannot join
- Patients younger than 18 years old. Patients without splenic arterial aneurysms
Trial locations and contacts
1 site in 1 country.
About this study
Spleen artery aneurysm represents the most common visceral aneurysm and the third most common splanchnic aneurysm. Most patients have no symptoms and are diagnosed as a part of other diagnostic focuses and examinations. The investigators present two patients with splenic artery aneurysms localized in the splenic hilum, who auspiciously undergo laparoscopic splenectomies with hem-o-lock clips in the vascular hilum without complications. These two cases showed that in addition to the numerous advantages of minimally invasive approaches, there is the possibility to improve laparoscopic technique in terms of safety and economic reasons by using hem - o - lock clips as a hemostatic technique securing the vascular elements of the splenic hilum.
- Conditions
- Arterial Splenic Aneurysm
- Being tested
- Laparoscopic Splenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic SplenectomyProcedure or surgery
Laparoscopic splenectomy by ligating the splenic artery
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Splenic Aneurysm
Asses the splenic hilium after operating a splenic arterial aneurysm. It will be measure by the follow up of the patient, by consult and physical examination.
Measured: July 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Jul 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Splenic AneurysmStudies 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
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tecnologico de Monterrey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Ruiz Velasco Santacruz, Tecnologico de Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502147
- Sponsor's protocol ID
- 168/7
- Status last verified
- Aug 2020
- First submitted
- 30 Jul 2020
- Last updated
- 6 Aug 2020
- 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 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Provide Vascular Control of Splenic Artery Aneurysm? Report of Two Cases
- ClinicalTrials.gov ID
- NCT04502147
- Acronym / sponsor ID
- 168/7
- Conditions
- Arterial Splenic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tecnologico de MonterreyUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 6 Aug 2020 (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.
Spleen artery aneurysm represents the most common visceral aneurysm and the third most common splanchnic aneurysm. Most patients have no symptoms and are diagnosed as a part of other diagnostic focuses and examinations. The investigators present two patients with splenic artery aneurysms localized in the splenic hilum, who auspiciously undergo laparoscopic splenectomies with hem-o-lock clips in the vascular hilum without complications. These two cases showed that in addition to the numerous advantages of minimally invasive approaches, there is the possibility to improve laparoscopic technique in terms of safety and economic reasons by using hem - o - lock clips as a hemostatic technique securing the vascular elements of the splenic hilum.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 41-year-old patient who was diagnosed with splenic artery enlargement on a routine ultrasound examination.
Key inclusion criteria (1 listed)
- Adults patients (>18 year old) with splenic arterial aneurysms
Key exclusion criteria (1 listed)
- Patients younger than 18 years old. Patients without splenic arterial aneurysms
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 SplenectomyLaparoscopic splenectomy by ligating the splenic artery | Procedure or surgery | – |
Primary outcome
Arterial Splenic Aneurysm
Time frame: July 2020
Asses the splenic hilium after operating a splenic arterial aneurysm. It will be measure by the follow up of the patient, by consult and physical examination.
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 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Arterial Splenic Aneurysm
Recruiting
Clinical Study on Laparoscopic Resection of Splenic Artery Aneurysm With Preservation of Spleen
Splenic Artery Aneurysm, Immune Function
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 Arterial Splenic Aneurysm, run by Tecnologico de Monterrey 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 Aug 2020. 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?
Arterial Splenic Aneurysm (time frame: July 2020). 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 6 Aug 2020.