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Evaluating small bowel wall in Crohn's disease: a comparison of MR enterography and contrast-enhanced ultrasound

Completed
Conditions
Crohn's disease
Inflammatory bowel disease
10017969
Registration Number
NL-OMON33145
Lead Sponsor
Rijnstate Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
150
Inclusion Criteria

- age between 18-65 years old;
- confirmed Crohn*s disease by ileocolonoscopy with biopsies;
- informed consent;

Exclusion Criteria

- cardiac failure (acute or chronic NYHA class II -IV) or other heart disease (unstable angina pectoris, recent acute coronary syndrome, severe rhythm disorders), right-to-left cardiac shunts, uncontrolled systemic hypertension, severe pulmonary hypetension and adult respiratory distress syndrome, which contraindicate the use of intravenous contrast during CE-US;
- chronic end stage kidney disease (risk for nephrogenic systemic sclerosis by use of MRI contrast agent: Gadolinium);
- patients having absolute contraindications for the MRI (intracorporal metal clips, neurostimulator, insuline pomp or pacemaker);
- patients with an acute abdomen and indication for surgery;
- pregnancy and lactation;

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The disease activity scores at CE-US (qualitative and quantitative), MRE and<br /><br>ileocolonoscopy and clinical activity score. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Not applicable</p><br>
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