Endoscopic Ultrasound Determines Disease Activity in Crohn's Disease And Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/7/2019
Start Date:January 4, 2019
End Date:January 2020
Contact:Vu Q Nguyen, M.D.
Email:vqnguyen@carilionclinic.org
Phone:5402069226

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Although Crohn's disease and ulcerative colitis are the main subtypes of inflammatory bowel
disease, they differ substantially in disease behavior, prognosis, and treatment paradigm.
However, making an accurate diagnosis of Crohn's disease versus ulcerative colitis and
assessing disease activity beyond the level of mucosal inflammation remain challenging with
contemporary modalities. The objective of the study is to determine the novel role of
endoscopic ultrasound in A) differentiating Crohn's colitis versus ulcerative colitis and B)
monitoring disease activity in these patients.

Crohn's disease (CD) and ulcerative colitis (UC) are two principal subtypes of inflammatory
bowel disease (IBD). Disease behavior, prognosis, and therapy differ substantially between
these two subtypes. However, up to 15% of patients may have misclassification of their IBD
subtypes leading to significant delay in appropriate management and prognostication. The
misclassification of CD and UC is due to limitations in contemporary modalities used to
diagnose these diseases. While CD involves transmural inflammation and UC is limited to
mucosal inflammation, the combination of endoscopy, histology, and cross-sectional imaging
typically used to establish the diagnosis do not reliably distinguish mucosal from submucosal
inflammation. Consequently, disease reclassification often occurs at the time of surgery when
transmural inflammation can be determined from the surgical specimen. At that time, medical
therapy has already failed. The optimal time for accurate IBD classification would be at the
initial diagnosis, allowing for appropriate targeted therapy to achieve optimal disease
outcomes.

Endoscopic ultrasound (EUS) can provide detailed information about luminal wall layers. To
date, the use of endoscopic ultrasound (EUS) for colorectal disease has been limited to
staging of subepithelial lesions and examining CD-related perianal complications. The
ultrasound miniprobe device (UM-2/3R, Olympus) is a thin ultrasound catheter that can be
passed through the colonoscope's accessory channel to perform detailed ultrasonic assessment
of any colon wall segments. Prior studies have demonstrated that the submucosal layer is
significant thicker in active CD compared to active UC, while active UC has thicker mucosal
layer comparatively. This study tests the hypothesis that the addition of the miniprobe
ultrasound catheter at the time of colonoscopy will help to differentiate active CD with
colonic involvement and UC from non-IBD controls by comparing the differential thickness in
the mucosal and submucosal layer among these groups of patients. Furthermore, the
investigators hypothesize that the thickness of differential wall layers in CD and UC
patients will correlate to clinical and endoscopic disease activity. The significance of
these findings will help establish an accurate diagnosis of IBD subtypes early in the disease
course and provide for a reliable method to monitor disease activity not only at the mucosal
layer but also in deeper luminal wall layers.

Inclusion Criteria:

- Adults patients ≥ 18 years of age with CD with at least colonic involvement, UC, or
non-IBD controls who have been referred for colonoscopy for clinical reasons. The
clinical reasons may include colorectal cancer screening, surveillance, diagnostic for
CD or UC flare, or gastrointestinal symptoms.

Exclusion Criteria:

- Pregnant patients.

- Patients with known current colorectal cancer, infectious colitis, diverticulitis, or
microscopic colitis.

- Patients who have undergone surgery involving the cecum or rectum.
We found this trial at
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Roanoke, Virginia
Phone: 540-206-9226
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