Crohn's disease inflammatory bowel disease
Conditions
Interventions
None listed
Sponsors
Alimentiv
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. An established diagnosis of CD. 2. Documented symptomatic stricturing small bowel CD in reach of colonoscopy (i.e., a portion of the stricture is located within 15 cm of the ileocecal valve or ileocecal anastomosis). 3. Anastomotic or naïve small bowel CD stricture(s) at the time of the baseline imaging assessment (CTE, MRE, or CT) 4. Clinical symptoms consistent with obstruction within 1 month of the baseline imaging.
Exclusion criteria
Exclusion criteria: 1. Internal penetrating disease as shown by fistula, abscess, or inflammatory mass (phlegmon) at baseline or during follow-up. A blind-ending sinus is not excluded. 2. Gastrointestinal malignancies. 3. More than 2 distal ileal strictures at the time of baseline imaging assessment (where 2 strictures within 3 cm are considered the same stricture; a long segment with multiple areas of narrowing or multiple strictures that have inflammation between them is counted as 1 stricture). 4. A terminal ileal stricture in a subject with end ileostomy, where the stricture is confined within the subcutaneous tissues and does not extend intra-abdominally. 5. A diverting loop ileostomy proximal to the dominant stricture. 6. Total proctocolectomy with an ileoanal or Kock pouch. 7. Stricturoplasty in the distal ileum. 8. Contraindication to CTE or MRE or inability to undergo CTE or MRE (e.g., claustrophobia). 9. Change in treatment for CD between baseline imaging assessment (CTE, MRE or CT) and informed consent, if imaging assessment is performed within 4 weeks prior to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validation of the PRO Responsiveness of SRI index | — |
Countries
Netherlands
Outcome results
None listed