High frequency and dynamic contrast-enhanced ultrasound for treatment follow up of patients with Crohn*s disease.

Completed

• Conditions: chronic intestinal inflammation; Crohn's disease; 10017969

• Registration Number: NL-OMON50449
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- acute deterioration of histologically confirmed Crohn*s disease with Harvey
Bradshow Index (clinical score) >= 8
- start of systemic medical treatment with TNF-a inhibitors (adalimumab or
infliximab)

Exclusion Criteria

- no thickened bowel segments found on ultrasound
- use of TNF-a inhibitor last 3 months
- pregnancy
- age<18years
- chronic obstructive lung disease
- acute coronary heart disease
- clinically unstable heart disease and/or
- earlier allergic reaction to Sonovue or to its components
- ongoing gastroenteritis
- presence of an intra-abdominal abscess or a fistula
- obesity (BMI>30 kg/m2)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ultrasound parameters: length affected intestine, wall thickness (mucosa,<br /><br>submucosa, muscularis propria, stratification), thick muscularis mucosae,<br /><br>fistula, stenosis, motility, creeping fat, vessel index CD, CEUS index, mean<br /><br>transit time, blood volume, blood flow.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Endoscopic disease activity, biochemical disease activity (inflammatory<br /><br>parameters), clinical disease activity (HBI).</p><br>