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

Completed

Conditions: Crohn's disease
inflammatory bowel disease
10018008
10003816

Registration Number: NL-OMON54948

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

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

* Isolated colonic stricture
* Endoscopic balloon dilation prior to baseline MRI or ultrasonography
* Pregnancy
* Age <18years
* Inability to give informed consent
* Ongoing gastroenteritis
* 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MRI: - - IVIM fractional perfusion - T2*-value - Quantitated intestinal<br /><br>motility Ultrasound: - Speed of velocity of shear-wave (m/s) - Mean transit<br /><br>time of intravascular contrast (s) - Time to peak (s) - Blood volume per tissue<br /><br>(mL/100 mL tissue) - Blood flow (m/s) - Time between arrival of oral contrast<br /><br>at the stricture and passage through the stricture - Amount of bowel movements<br /><br>before oral contrast passes through the stricture Clinical: - Response to<br /><br>therapy after 26 weeks of treatment (defined by the continuation of medical<br /><br>therapy and the absence of the need for an intervention (balloon dilation or<br /><br>surgery)) Histopathology: - Inflammation grades - Fibrosis grades</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Conventional MRI parameters: length of the stricture, prestenotic dilatation,<br /><br>bowel wall thickness, bowel wall edema, bowel wall enhancement and<br /><br>stratification, fatty wrapping, fistulas and abscesses. - Conventional<br /><br>ultrasound parameters: length of the stricture, prestenotic dilation, bowel<br /><br>wall thickness, wall layer stratification, fatty wrapping, Doppler signal,<br /><br>motility, presence of lymph nodes, abscesses, fistulas. - Clinical information:<br /><br>medical history, sex, age, weight, height, current and previous medication -<br /><br>Clinical activity scores: Harvey-Bradshaw Index (HBI) and Crohn*s Disease<br /><br>Obstructive Score (CDOS) - Blood: C-reactive protein, hemoglobin, platelet<br /><br>count, leukocyte count, erythrocyte count and albumin. - Faecal calprotectin</p><br>