Validation of an Intestinal Ultrasound Evaluating Inflammation and Treatment Response in Crohn´s Disease (USE-IT): A Prospective Multicenter Study
- Conditions
- Crohn disease [regional enteritis]K50
- Registration Number
- DRKS00030595
- Lead Sponsor
- International Bowel Ultrasound Group e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 111
Participants must meet each of the following criteria for enrolment into the study:
1. Confirmed diagnosis of CD according to standard clinical, endoscopic, and histologic criteria of at least 3 months duration
2. Adults 18 years of age or older
3. Moderate to severely active CD defined by:
a. Active symptoms with an HBI score = 5, and
b. Bowel wall inflammation defined as BWT > 3 mm in at least 1 segment of the ileum or colon as determined by IUS
4. Patients with planned introduction of an SOC biologic and/or JAK inhibitor therapy approved for CD as per their treating gastroenterologist to treat active disease
5. Written informed consent must be obtained and documented
Patients who exhibit any of the following conditions are to be excluded from the study:
1. Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified
2. Patients with prior intestinal surgery
3. Disease-related structural bowel complications as defined by CONSTRICT criteria:11
a. Localized luminal narrowing (luminal diameter reduction of at least 50% relative to normal adjacent bowel loop), and
b. Bowel wall thickening (25% increase relative to adjacent unaffected bowel), and
c. Either: maximum associated small bowel dilation (luminal diameter greater than or equal to 3 cm) OR inability to pass an adult or pediatric colonoscope through the narrowed area prior to dilation and unequivocal proximal small bowel dilation (but may be less than 3 cm). Endoscopic diagnosis of stricture should be within 6 months of MRE
4. Disease-related penetrating complications (excluding perianal fistulizing disease; patients with perianal disease are eligible if there is additional inflammation in another bowel segment [other than the rectum])
5. Contraindication to IC or MRE
6. BMI greater than 35 at time of screening or other characteristics considered likely to preclude IUS visualization of all bowel segments
7. Disease limited to the rectum
8. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant’s ability to participate fully in the study
9. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant’s ability to comply with the study procedures
10. Pregnancy and female patients of child-bearing potential planning a pregnancy during the study period
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The longitudinal and construct validity and treatment responsiveness of an IUS CD activity index in an adult population with moderate to severely active CD
- Secondary Outcome Measures
Name Time Method