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Stricturing Crohn*s Disease assessment using advanced ultrasound and magnetic resonance imaging techniques for evaluation of inflammation and fibrosis

Stricturing Crohn*s Disease assessment using advanced ultrasound and magnetic resonance imaging techniques for evaluation of inflammation and fibrosis - Ultrasound and magnetic resonance imaging in strictures in Crohn's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54948
Enrollment
42
Registered
2019-09-12
Start date
2019-12-17
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease inflammatory bowel disease

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 23, 2026