Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06553105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis and Clinical Presentation of Iliac Graft-Enteric Fistula: A Case Report
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-10', 'studyFirstSubmitDate': '2024-08-10', 'studyFirstSubmitQcDate': '2024-08-10', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnosis of fistula by ct scan', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['case-report; CT scan; Diagnosis; Digestive System Fistula; Gastrointestinal Hemorrhage; Iliac Graft-Enteric Fistula.'], 'conditions': ['Case-report', 'Diagnosis', 'Digestive System Fistula', 'Gastrointestinal Hemorrhage', 'Iliac Graft-Enteric Fistula']}, 'descriptionModule': {'briefSummary': 'Abstract\n\nIntroduction:\n\nAorto-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.\n\nCase Presentation:\n\nWe 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.\n\nClinical Discussion:\n\nDiagnosing 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.\n\nConclusion:\n\nAorto-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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'one man', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nn/a\n\nExclusion Criteria:\n\nn/a'}, 'identificationModule': {'nctId': 'NCT06553105', 'briefTitle': 'Diagnosis and Clinical Presentation of Iliac Graft-Enteric Fistula: A Case Report', 'organization': {'class': 'OTHER', 'fullName': 'Golestan University of Medical sciences'}, 'officialTitle': 'Department of Radiology, School of Medicine, 5th Azar Hospital, Gorgan, Golestan, Iran', 'orgStudyIdInfo': {'id': 'there is no id'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ct scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'use ct scan for diagnosis fistula'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Golestan University of Medical sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Radiology, School of Medicine, 5th Azar Hospital, Gorgan, Golestan, Iran', 'investigatorFullName': 'Reza zahedpasha', 'investigatorAffiliation': 'Golestan University of Medical sciences'}}}}