- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03436966
Role of Multislice CT in Diagnosis of Inflammatory Bowel Disease
February 17, 2018 updated by: Heba Abo Elmakarem Ahmed, Assiut University
Role Of Computed Tomography Enterography in Diagnosis of Inflammatory Bowel Disease
Aim of the work: To evaluate the role of CT in diagnosis of IBD
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HMakarem am, residant
- Phone Number: 01122112561
- Email: hoobamakarem@gmail.com
Study Contact Backup
- Name: Mzidan z, Asst.prof
- Phone Number: 01001121365
- Email: mzidan74@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 80 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Number of 30 Patients with inflammatory bowel disease will be included in the study.
- 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]
- 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.
Description
Inclusion Criteria:
- Patient in the age group between 15&40 and another age group between 50&80 with inflammatory bowel disease.
Exclusion Criteria:
- Patients with any general contraindication to Radiation of CT especially pregnant women.
- Patients with any general contraindication to contrast, impaired renal function & hypersensitivity.
- Patients of the age group below 15 years old.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of inflammatory bowel disease by MSCT enterography
Time Frame: baseline
|
detect the early complication of the disease: fistula, stricture, fibofatty changes by enterography
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: shreef abd, prof, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2018
Primary Completion (ANTICIPATED)
September 1, 2019
Study Completion (ANTICIPATED)
October 1, 2019
Study Registration Dates
First Submitted
February 13, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (ACTUAL)
February 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 20, 2018
Last Update Submitted That Met QC Criteria
February 17, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSCT in IBD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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