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Role of Multislice CT in Diagnosis of Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03436966
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Heba Abo Elmakarem Ahmed, Assiut University

Brief Summary:
Aim of the work: To evaluate the role of CT in diagnosis of IBD

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Device: MULTI SLICE CT

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 [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Role Of Computed Tomography Enterography in Diagnosis of Inflammatory Bowel Disease
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Intervention Details:
  • Device: MULTI SLICE CT
    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.


Primary Outcome Measures :
  1. Diagnosis of inflammatory bowel disease by MSCT enterography [ Time Frame: baseline ]
    detect the early complication of the disease: fistula, stricture, fibofatty changes by enterography



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436966


Contacts
Contact: HMakarem am, residant 01122112561 hoobamakarem@gmail.com
Contact: Mzidan z, Asst.prof 01001121365 mzidan74@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Study Director: shreef abd, prof Assiut University

Publications of Results:
Responsible Party: Heba Abo Elmakarem Ahmed, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03436966     History of Changes
Other Study ID Numbers: MSCT in IBD
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis