Crohn's Disease
Conditions
Interventions
None
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: • Endoscopic or histological confirmed Crohn’s Disease • Age = 18 year • One or more small bowel stricture(s) confirmed on endoscopy and/or cross-sectional imaging • Scheduled for anti-inflammatory treatment or surgery
Exclusion criteria
Exclusion criteria: • Isolated colonic stricture • Endoscopic balloon dilation prior to baseline MRI or ultrasonography • Pregnancy • Age <18years • Inability to give informed consent • Ongoing gastroenteritis • No stricture visible on ultrasound and/or MRI • Specifically for MRI o General contraindications for MRI (MRI-incompatible implants, pacemaker, claustrophobia, and pregnancy) • Specifically for CEUS o Chronic obstructive lung disease o Acute coronary heart disease o Clinically unstable heart disease o Previous allergic reaction to Sonovue or to its components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI: -MT-ratio -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 -Number of bowel movements before oral contrast passes through the stricture Clinical: -Response to therapy after 26 weeks of treatment (defined by the continuation of baseline medical therapy without adding other anti-inflammatory medication, the absence of the need for an intervention (balloon dilation or surgery) and no clinical deterioration based on clinical activity indices9,31) 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, presence of lymph nodes, 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 Index31 (HBI) and Crohn’s Disease Obstructive Score9 (CDOS) - Blood: C-reactive protein, hemoglobin, platelet count, leukocyte count, erythrocyte count and albumin - Faecal calprotectin | — |
Contacts
Public ContactFloris de Voogd
Amsterdam UMC/AMC
Outcome results
None listed