Anatomical Variant of the Inferior Vena CavaNCT06312878
CT Features of Interrupted Inferior Vena Cava With Azygous Continuation
An observational study of Anatomical Variant of the Inferior Vena Cava, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Inferior vena cava (IVC) is the largest vein is the body, draining blood from the abdomen, pelvis and lower extremities. IVC anomalies can be congenital or acquired. The origins of these anomalies are not entirely clear, and their incidence is uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomical Variant of the Inferior Vena Cava
- What is being tested?
- Describe the anatomy of the IVC in the case of an anatomical variant
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 29 Apr 2024
- 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: Patients with interrupted IVC with azygous continuation on CT scan
Who may be able to join
- All patients with interrupted IVC with azygous continuation on CT scan were included in this study.
Who cannot join
- Patients under 18 years of age
- Patients no available CT scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT Features of Interrupted Inferior Vena Cava With Azygous Continuation : a Retrospective Study
Inferior vena cava (IVC) is the largest vein is the body, draining blood from the abdomen, pelvis and lower extremities. IVC anomalies can be congenital or acquired.
The origins of these anomalies are not entirely clear, and their incidence is uncertain.
Imaging plays a pivotal role in diagnosis to prevent misinterpretation. CT scan is a quick, available, and suitable imaging modality in emergency setting.
The aim of this retrospective monocentric study was of describe CT features of interrupted suprarenal inferior vena cava with azygous continuation.
- Being tested
- Describe the anatomy of the IVC in the case of an anatomical variant
- Keywords
- Interrupted vena cava, Azygous continuation, Polysplenia, CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Describe the anatomy of the IVC in the case of an anatomical variantOther
Evaluated technique by collecting data from the medical record.
| Study group | Role | What they receive |
|---|---|---|
| Included patients | All patients with interrupted IVC with azygous continuation on CT scan. Receives: Other: Describe the anatomy of the IVC in the case of an anatomical variant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation
The number of infrarenal inferior vena cava was recorded for each patient.
Measured: Day : 1
Secondary outcomes (9)
Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation
The type of drainage of the left renal vein was recorded for each patient.
Measured: Day : 1
Describe association with polysplenic syndrome
Measurement of splenic laterality
Measured: Day : 1
Describe association with polysplenic syndrome
Measurement of stomach laterality
Measured: Day : 1
Describe association with polysplenic syndrome
Measurement of liver morphology
Measured: Day : 1
Describe association with polysplenic syndrome
Measurement of the preduodenal portal vein
Measured: Day : 1
Describe association with polysplenic syndrome
Measurement of pancreatic and intestinal rotation malformations
Measured: Day : 1
Describe association with polysplenic syndrome
Measurement of cardiopulmonary malformations
Measured: Day : 1
Describe circumstances of discovering the interrupted IVC
The circumstances of discovering the interrupted IVC were also documented from clinical records.
Measured: Day : 1
Describe circumstances of discovering the interrupted IVC
An history of thrombotic events was also documented from clinical records.
Measured: Day : 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Mar 2024
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomical Variant of the Inferior Vena CavaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain GRANGE, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312878
- Sponsor's protocol ID
- IRBN052024/CHUSTE
- Status last verified
- Jun 2024
- First submitted
- 4 Mar 2024
- Last updated
- 21 Jun 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Features of Interrupted Inferior Vena Cava With Azygous Continuation : a Retrospective Study
- ClinicalTrials.gov ID
- NCT06312878
- Acronym / sponsor ID
- IRBN052024/CHUSTE
- Keywords
- Interrupted vena cava, Azygous continuation, Polysplenia, CT scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 15 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.
Inferior vena cava (IVC) is the largest vein is the body, draining blood from the abdomen, pelvis and lower extremities. IVC anomalies can be congenital or acquired.
The origins of these anomalies are not entirely clear, and their incidence is uncertain.
Imaging plays a pivotal role in diagnosis to prevent misinterpretation. CT scan is a quick, available, and suitable imaging modality in emergency setting.
The aim of this retrospective monocentric study was of describe CT features of interrupted suprarenal inferior vena cava with azygous continuation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Other: Describe the anatomy of the IVC in the case of an anatomical variantAll patients with interrupted IVC with azygous continuation on CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with interrupted IVC with azygous continuation on CT scan
Key inclusion criteria (1 listed)
- All patients with interrupted IVC with azygous continuation on CT scan were included in this study.
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients no available CT scan.
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 |
|---|---|---|
| Describe the anatomy of the IVC in the case of an anatomical variantEvaluated technique by collecting data from the medical record. | Other | Included patients |
Primary outcome
Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation
Time frame: Day : 1
The number of infrarenal inferior vena cava was recorded for each patient.
9 secondary outcomes
Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation
Time frame: Day : 1
Describe association with polysplenic syndrome
Time frame: Day : 1
Describe association with polysplenic syndrome
Time frame: Day : 1
Describe association with polysplenic syndrome
Time frame: Day : 1
Describe association with polysplenic syndrome
Time frame: Day : 1
Describe association with polysplenic syndrome
Time frame: Day : 1
Describe association with polysplenic syndrome
Time frame: Day : 1
Describe circumstances of discovering the interrupted IVC
Time frame: Day : 1
Describe circumstances of discovering the interrupted IVC
Time frame: Day : 1
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 21 Jun 2024.
- Individual participant dataSharing planned: No
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.
Sylvain GRANGE, MD principal investigator
CHU de Saint-Etienne
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 Anatomical Variant of the Inferior Vena Cava, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 2 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 21 Jun 2024. 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 France. 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?
Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation (time frame: Day : 1). 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 21 Jun 2024.