Endoscopic detection of small bowel dysplasia and cancer in patients with jejunoileal Crohn*s disease :prospective study in a cohort of high risk patients

Completed

• Conditions: 10017969; Crohn's disease; Inflammatory bowel disease

• Registration Number: NL-OMON37771
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- 18 years or older
- M. Crohn of the jejunum and/or ileum with or without other involved areas of the gastrointestinal system
- Lesions of the small intestine which exist for at least 10 years (patient with a ileocolonic anastomosis with isolated ileal lesions for more than 10 years may be included, but this sub group may only be 30% of the included patients).
- Crohn lesions accessible by endoscopy
- CT scan or MRI of the small intestine in the last 12 months to locate the lesions.
- Signed informed consent

Exclusion Criteria

- History of dysplasia or cancer of the small intestine
- Contra-indication for an endoscopy
- Not willing to participate
- Pregnancy
- Participating in an other clinical trial

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>To determin the frequency of small bowel dysplasia and adenoma carcinoma by<br /><br>endoscopy with biopsies in a population of Crohn's disease patients with a high<br /><br>risk of dysplasia and adenomacacinoma due to a disease history of more than ten<br /><br>years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1.2.1. Evaluation of the feasibility of endoscopic surveillance defined as<br /><br>success rate of reaching the small intestine lesions endoscopicly and to<br /><br>collect biopsies<br /><br>1.2.2. Evaluation of the importance of indigo carmine colouring for diagnosis<br /><br>of dysplasia and cancer of the small intestine<br /><br>1.2.3. Determination of the factors associated with the presence of dysplasia<br /><br>and cancer.<br /><br>1.2.4. Evaluation of the complication caused by the endoscopic procedures and<br /><br>biopsies</p><br>