Assessment of the performance of the new generation Pillcam colon capsule (PCCE 2) in Crohn's disease: an exploratory study.

Completed

Conditions: Crohn's disease
Inflammatory bowel disease
10017969

Registration Number: NL-OMON35999

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

* Active Crohn's disease with CDAI > 150
* Elevated serum CRP (> 5 mg/l) and fecal calprotectin (> 200 ng/mg)
* Prior documentation of colonic involvement by Crohn's disease in at least one segment of the colon and more severe than only aphthous lesions
* Colonoscopy clinically indicated

Exclusion Criteria

* Any contraindication for colonoscopy or colon capsule examination including swallowing disorders, severe congestive heart failure, renal insufficiency
* More than 1 resectional surgery for CD
* Subtotal or total colectomy
* Severely active fistulising disease
* Jejunal Crohn's disease
* HIgh suspicion of small bowel strictures
* Short bowel syndrome or stoma

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Diagnostic yield of PCCE 2 findings with attention to the type, size and<br /><br>location of lesions caused by Crohn's disease<br /><br>2. Comparison of findings at PCCE 2 Pillcam recording and optical colonoscopy<br /><br>and validation of a Pillcam inflammation score using endoscopic scores as<br /><br>comparator</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Safety and tolerability of the preparation procedure, the Pillcam<br /><br>examination and the optical colonoscopy<br /><br>2. Determine inter-observer variability by serial readings of Pillcam recordings<br /><br>3. Examine sensitivity and specificity of colonic Pillcam to detect mucosal<br /><br>healing in Crohn's patients before and after treatment with Infliximab or<br /><br>Adalimumab<br /><br>4. Correlation of PCCE 2 findings and inflammatory burden measured by serum<br /><br>CRP and fecal Calprotectin</p><br>