No registrations found.
ID
Source
Brief title
Health condition
Crohn's Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Bowel stricturing in Crohn’s disease (CD) occurs frequently.1 Whereas inflammatory strictures might benefit from anti-inflammatory therapy, fibrotic strictures often need a surgical approach.1,2 However, current imaging biomarkers are unable to adequately determine stricture composition.3
Ultrasound and MRI are frequently used in the evaluation of CD activity.4 Previous studies showed that advanced modalities of both techniques are promising in stricture characterization.3,5 However, data is scarce and most studies did not evaluate the clinical relevance of advanced imaging techniques. Therefore, we will evaluate state-of-the-art cross-sectional imaging parameters to define stricture composition and to assess their clinical value.
Objectives: The primary aims of this study are to evaluate advanced MRI and ultrasounds techniques to:
1. Identify advanced imaging techniques that correlate with stricture composition as defined by the histopathologic degree of fibrosis and inflammation in the resection specimen
2. Identify advanced imaging parameters that distinguish patients responding to anti-inflammatory therapy and patients requiring surgery
Study objective
Advanced intestinal ultrasound and MRE techniques could differentiate between inflammatory and fibrotic strictures in Crohn's Disease
Study design
Baseline, medication group will receive a second ultrasound and MRE after 26 weeks
Intervention
None
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
• 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9105 |
| Other | METC AMC : METC 2019_168 |