Ulcerative Colitis Clinical Trial
— EUSIBDOfficial title:
Endoscopic Ultrasound Determines Disease Activity in Crohn's Disease And Ulcerative Colitis
NCT number | NCT03863886 |
Other study ID # | 2694 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 4, 2019 |
Est. completion date | June 2022 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Carilion Clinic | Roanoke | Virginia |
Lead Sponsor | Collaborator |
---|---|
Carilion Clinic |
United States,
Câr?âna ET, Gheonea DI, Saftoiu A. Advances in endoscopic ultrasound imaging of colorectal diseases. World J Gastroenterol. 2016 Feb 7;22(5):1756-66. doi: 10.3748/wjg.v22.i5.1756. Review. — View Citation
Ellrichmann M, Wietzke-Braun P, Dhar S, Nikolaus S, Arlt A, Bethge J, Kuehbacher T, Wintermeyer L, Balschun K, Klapper W, Schreiber S, Fritscher-Ravens A. Endoscopic ultrasound of the colon for the differentiation of Crohn's disease and ulcerative colitis — View Citation
Gomollón F, Dignass A, Annese V, Tilg H, Van Assche G, Lindsay JO, Peyrin-Biroulet L, Cullen GJ, Daperno M, Kucharzik T, Rieder F, Almer S, Armuzzi A, Harbord M, Langhorst J, Sans M, Chowers Y, Fiorino G, Juillerat P, Mantzaris GJ, Rizzello F, Vavricka S, — View Citation
Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, Burisch J, Gecse KB, Hart AL, Hindryckx P, Langner C, Limdi JK, Pellino G, Zagórowicz E, Raine T, Harbord M, Rieder F; European Crohn's and Colitis Organisation [ECCO]. Third — View Citation
Tontini GE, Vecchi M, Pastorelli L, Neurath MF, Neumann H. Differential diagnosis in inflammatory bowel disease colitis: state of the art and future perspectives. World J Gastroenterol. 2015 Jan 7;21(1):21-46. doi: 10.3748/wjg.v21.i1.21. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Active Crohn's disease has significantly thicker submucosa layer compared to patients with active ulcerative colitis and non-inflammatory bowel disease controls. | We are measuring the different colon wall layer thickness including the mucosa, submucosa, muscularis propria, and total wall layer (in mm) using the endoscopic ultrasound device and comparing the different levels of colon wall layer thickness between patients with active versus inactive ulcerative colitis, active versus inactive Crohn's disease, and comparing those to controls. | Day 1 | |
Secondary | The thickness of the submucosa layer in Crohn's disease patients correlates to the degree of disease activity as measured by the Harvey-Bradshaw clinical index and Simple Endoscopic Score index. | We will correlate the thickness (in mm) of the submucosa layer in Crohn's disease patients measured by endoscopic ultrasound to the degree of disease activity at the time of procedure as measured by the Harvey-Brashaw index and Simple Endoscopic Score (SES-CD) index. | Day 1 | |
Secondary | The thickness of the mucosa layer in ulcerative colitis patients correlates to the degree of disease activity as measured by the Mayo score index. | We will correlate the thickness (in mm) of the mucosa layer in ulcerative colitis patients measured by endoscopic ultrasound to the degree of disease activity at the time of procedure as measured by the Mayo score index. | Day 1 |
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