Crohn's disease inflammatory bowel disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: * Endoscopical or histological confirmed Crohn*s Disease * Age * 18 year * Scheduled for surgical small bowel segment resection * One or more small bowel stricture(s) confirmed on endoscopy and/or cross-sectional imaging that is scheduled for anti-inflammatory treatment
Exclusion criteria
Exclusion criteria: * Isolated colonic stricture * Endoscopic balloon dilation prior to baseline MRI or ultrasonography * Pregnancy * Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI: - - IVIM fractional perfusion - T2*-value - Quantitated intestinal motility Ultrasound: - Speed of velocity of shear-wave (m/s) - Mean transit time of intravascular contrast (s) - Time to peak (s) - Blood volume per tissue (mL/100 mL tissue) - Blood flow (m/s) - Time between arrival of oral contrast at the stricture and passage through the stricture - Amount of bowel movements before oral contrast passes through the stricture Clinical: - Response to therapy after 26 weeks of treatment (defined by the continuation of medical therapy and the absence of the need for an intervention (balloon dilation or surgery)) Histopathology: - Inflammation grades - Fibrosis grades | — |
Secondary
| Measure | Time frame |
|---|---|
| - Conventional MRI parameters: length of the stricture, prestenotic dilatation, bowel wall thickness, bowel wall edema, bowel wall enhancement and stratification, fatty wrapping, fistulas and abscesses. - Conventional ultrasound parameters: length of the stricture, prestenotic dilation, bowel wall thickness, wall layer stratification, fatty wrapping, Doppler signal, motility, presence of lymph nodes, abscesses, fistulas. - Clinical information: medical history, sex, age, weight, height, current and previous medication - Clinical activity scores: Harvey-Bradshaw Index (HBI) and Crohn*s Disease Obstructive Score (CDOS) - Blood: C-reactive protein, hemoglobin, platelet count, leukocyte count, erythrocyte count and albumin. - Faecal calprotectin | — |
Countries
Netherlands