Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-04 @ 8:51 PM
Study NCT ID:
NCT03436966
Status:
UNKNOWN
Last Update Posted:
2018-02-20
First Post:
2018-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Multislice CT in Diagnosis of Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-17', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of inflammatory bowel disease by MSCT enterography', 'timeFrame': 'baseline', 'description': 'detect the early complication of the disease: fistula, stricture, fibofatty changes by enterography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '15168363', 'type': 'RESULT', 'citation': 'Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004 May;126(6):1504-17. doi: 10.1053/j.gastro.2004.01.063.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the work: To evaluate the role of CT in diagnosis of IBD', 'detailedDescription': 'Inflammatory bowel disease (IBD): is a chronic idiopathic disease affecting the gastrointestinal (GI) tract that is comprised of two separate, but related intestinal disorders; Crohn s disease (CD) and ulcerative colitis (UC), IBD is thought to result from an exaggerated and inappropriate immune response to gut luminal microbes in genetically, susceptible individuals who are exposed to environmental risk factors. IBD is most common in North America and western and northern Europe, where incidence rates for UC and CD range from 2.2-24.3 per 100000 person years, It is estimated that more than 1.4 million Americans and as many as 2.5-3 million, Europeans have IBD. While UC and CD share some features, the diseases are distinct. Perhaps the most important differences are that while the chronic inflammation seen in UC is limited to the large intestine and affects only the intestinal mucosa, the inflammation in CD can occur at any location(s) along the GI tract and is often transmural, predisposing patients with CD to the development of penetrating (fistulizing) and fibro stenotic (stricturing) phenotypes that are not typically seen in UC. In some cases, UC and CD are not distinguishable and a diagnosis of IBD unclassified (IBD-U) is made although clinical features of IBD-U tend to mirror those of UC Clinical manifestations of UC include diarrhea, with or without blood, abdominal pain, tenesmus, and fecal urgency, while the manifestations of CD are more variable depending on the extent and location of the GI inflammation. CD with predominantly colonic involvement often presents in similar fashion to UC whereas in small bowel CD, diarrhea and rectal bleeding are seen less frequently and symptoms, fever, fatigue and weight loss are common.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Number of 30 Patients with inflammatory bowel disease will be included in the study.\n* CT scans are typically performed for IBD evaluation following administration of both oral and IV contrast to detect bowel wall abnormalities and abnormal enhancement\\[6\\]\n* Conventional CT uses positive enteral contrast agents, usually water soluble containing solutions, which increase the attenuation of the bowel lumen and of bowel wall abnormalities and extraluminal fluid collections.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient in the age group between 15\\&40 and another age group between 50\\&80 with inflammatory bowel disease.\n\nExclusion Criteria:\n\n* Patients with any general contraindication to Radiation of CT especially pregnant women.\n* Patients with any general contraindication to contrast, impaired renal function \\& hypersensitivity.\n* Patients of the age group below 15 years old.'}, 'identificationModule': {'nctId': 'NCT03436966', 'briefTitle': 'Role of Multislice CT in Diagnosis of Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role Of Computed Tomography Enterography in Diagnosis of Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'MSCT in IBD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MULTI SLICE CT', 'type': 'DEVICE', 'description': 'Positive enteric contrast, can, however, obscure IV contrast enhancement of the bowel wall. In addition, positive oral contrast agents opacify but do not always well distend the bowel. IV contrast is administered and images are acquired in the portal venous phase, which is optimized for visceral organ evaluation.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'HMakarem am, residant', 'role': 'CONTACT', 'email': 'hoobamakarem@gmail.com', 'phone': '01122112561'}, {'name': 'Mzidan z, Asst.prof', 'role': 'CONTACT', 'email': 'mzidan74@yahoo.com', 'phone': '01001121365'}], 'overallOfficials': [{'name': 'shreef abd, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Heba Abo Elmakarem Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}