Crohn's disease inflammatory bowel disease
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Histological confirmed Crohn*s Disease * Age * 18 year * Stricturing disease diagnosed by endoscopy and/or radiologic imaging * Receive medical treatment, endoscopic dilation or surgery
Exclusion criteria
Exclusion criteria: * * Time between ultrasonography start of medical treatment and baseline ultrasonography and interventional treatment exceeding 8 weeksexceeding two weeks * Endoscopic balloon dilation prior to baseline ultrasonography * Pregnancy * Chronic obstructive lung disease * Acute coronary heart disease * Clinically unstable heart disease * Previous allergic reaction to Sonovue or to its components * Ongoing gastroenteritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of parameters between intervention vs no intervention group: * Speed of velocity of shear-wave (m/s) * Mean transit time of intravascular contrast (second) * Time to peak (second) * Blood volume per tissue (mL/100 mL tissue) * Blood flow (meter per second) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Location of bowel wall thickening (small intestine, terminal ileum, ascendens, transversum, descendens, sigmoid, rectum) * Wall layer thickness of mucosa, submucosa, muscularis propria, serosa (mm) * Length of affected intestine (cm) * Bowel wall width (mm) * Preserved bowel wall stratification (yes/no) * Preserved haustration (yes/no) * Loss of bowel motility (yes/no) * Prestenotic dilation (yes/no) * Minimal lumen width (mm) * Fatty wrapping (yes/no) * Abscesses (yes/no) * Fistula (yes/no) * Enlarged lymph nodes (yes/no) * Colour Doppler Activtiy (yes/no) * Location of Doppler activity (within the bowel wall/outside of bowel wall) * Response of medical treatment within 52 weeks defined as: o Clinical improvement defined as a decrease in CDAI*100 points from baseline AND/OR o Clinical remission defined as CDAI5 mg/L and fecal calprotectin >50 mg/g)) Histological parameters: Histologically, mucosa, submucosa, muscularis propria and serosa will be examined on the following: cryptitis, ulcerations, crypt abscessess, occurrence of neutrophilic, lymphocytic en eosinophilic cells, extent of fibrosis, muscle layer width and expansion of muscle layer, collagen deposition, fibroblast proliferation, adipose tissue proliferation | — |
Countries
Netherlands
Outcome results
None listed