Case-reportNCT06553105
Diagnosis and Clinical Presentation of Iliac Graft-Enteric Fistula: A Case Report
An observational study of Case-report and Diagnosis, run by Golestan University of Medical sciences.
Trial summary
Abstract Introduction: Aorto-enteric fistula (AEF) is a life-threatening complication arising from abnormal connections between the gastrointestinal tract and major arteries. One uncommon type, iliac artery-enteric fistula (IEF), can occur following vascular interventions such as arterial stent-graft placement. Read more about this study
- Who is it for?
- Ages 40 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Case-report, Diagnosis, Digestive System Fistula
- What is being tested?
- ct scan
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2024to 13 Aug 2024
- How long will I take part?
- 10 Days
- 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 40 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: one man
Who may be able to join
- n/a
Who cannot join
- n/a
About this study
Official title: Department of Radiology, School of Medicine, 5th Azar Hospital, Gorgan, Golestan, Iran
Abstract
Introduction:
Read more
Aorto-enteric fistula (AEF) is a life-threatening complication arising from abnormal connections between the gastrointestinal tract and major arteries. One uncommon type, iliac artery-enteric fistula (IEF), can occur following vascular interventions such as arterial stent-graft placement.
Case Presentation:
We report the case of a 47-year-old male presenting with hematemesis and abdominal pain, who was diagnosed with an iliac graft-enteric fistula. Timely recognition and management were crucial for a favorable outcome.
Clinical Discussion:
Diagnosing AEFs remains challenging, requiring a multidisciplinary approach and high clinical suspicion. While computed tomography angiography (CTA) is commonly used for diagnosis, its sensitivity may be limited, emphasizing the importance of integrating clinical history and findings. Management strategies vary based on etiology and patient status, with surgery being pivotal.
Conclusion:
Aorto-enteric fistula, which can arise from a thrombosed graft, presents diagnostic challenges due to its rare formation. In patients with a history of vascular interventions and gastrointestinal bleeding, AEF should be considered. This case underscores the need for heightened awareness among healthcare professionals regarding AEF diagnosis and management to reduce severe morbidity, mortality, and prolonged hospital stays.
- Conditions
- Case-report, Diagnosis, Digestive System Fistula, Gastrointestinal Hemorrhage, Iliac Graft-Enteric Fistula
- Being tested
- ct scan
- Keywords
- case-report; CT scan; Diagnosis; Digestive System Fistula; Gastrointestinal Hemorrhage; Iliac Graft-Enteric Fistula.
- Medical subject headings
- Disease, Digestive System Fistula, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ct scanDiagnostic test
use ct scan for diagnosis fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of fistula by ct scan
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start11 Aug 2024 (estimated)
- Primary completion12 Aug 2024 (estimated)
- Study completion13 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Case-reportStudies 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
- 1 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Golestan University of Medical sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza zahedpasha, Golestan University of Medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553105
- Sponsor's protocol ID
- there is no id
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Radiology, School of Medicine, 5th Azar Hospital, Gorgan, Golestan, Iran
- ClinicalTrials.gov ID
- NCT06553105
- Acronym / sponsor ID
- there is no id
- Conditions
- Case-report, Diagnosis, Digestive System Fistula, Gastrointestinal Hemorrhage, Iliac Graft-Enteric Fistula
- Keywords
- case-report; CT scan; Diagnosis; Digestive System Fistula; Gastrointestinal Hemorrhage; Iliac Graft-Enteric Fistula.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Golestan University of Medical sciencesUniversity, hospital or other
- Study start
- 11 Aug 2024 (estimated)
- Primary completion
- 12 Aug 2024 (estimated)
- Study completion
- 13 Aug 2024 (estimated)
- First posted
- 14 Aug 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.
Abstract
Introduction:
Aorto-enteric fistula (AEF) is a life-threatening complication arising from abnormal connections between the gastrointestinal tract and major arteries. One uncommon type, iliac artery-enteric fistula (IEF), can occur following vascular interventions such as arterial stent-graft placement.
Case Presentation:
We report the case of a 47-year-old male presenting with hematemesis and abdominal pain, who was diagnosed with an iliac graft-enteric fistula. Timely recognition and management were crucial for a favorable outcome.
Clinical Discussion:
Diagnosing AEFs remains challenging, requiring a multidisciplinary approach and high clinical suspicion. While computed tomography angiography (CTA) is commonly used for diagnosis, its sensitivity may be limited, emphasizing the importance of integrating clinical history and findings. Management strategies vary based on etiology and patient status, with surgery being pivotal.
Conclusion:
Aorto-enteric fistula, which can arise from a thrombosed graft, presents diagnostic challenges due to its rare formation. In patients with a history of vascular interventions and gastrointestinal bleeding, AEF should be considered. This case underscores the need for heightened awareness among healthcare professionals regarding AEF diagnosis and management to reduce severe morbidity, mortality, and prolonged hospital stays.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- one man
Key inclusion criteria (1 listed)
- n/a
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| ct scanuse ct scan for diagnosis fistula | Diagnostic test | – |
Primary outcome
diagnosis of fistula by ct scan
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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 Case-report and Diagnosis, run by Golestan University of Medical sciences.
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: status not confirmed, as of the sponsor's last update on 14 Aug 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?
Results are not available in the source record.
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?
diagnosis of fistula by ct scan (time frame: one day). 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 Aug 2024.