The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity in patients with suspected CD compared to the traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality
This is a prospective, blinded, multicenter study of the diagnostic validity, inter-observer agreement, image quality and subjective experience of discomfort with PCCE, MREC and US in patients with suspected CD. Ileocolonoscopy serves as the diagnostic gold standard. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, PCCE, MREC and US. All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing PCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
153
Sydvestjysk sygehus
Esbjerg, Denmark
Odense university Hospital
Odense, Denmark
Sygehus Lillebaelt
Vejle, Denmark
Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD
Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD located in the terminal ileum and colon (per patient \& per segment). Ileocolonoscopy serves as gold standard
Time frame: 36 months
Correlation of disease severity
Correlation of disease severity assessed with PCCE, MREC, US and ileocolonoscopy
Time frame: 36 months
Inter-observer agreement
Inter-observer agreement with PCCE, MREC, US and ileocolonoscopy
Time frame: 36 months
Diagnostic yield of proximal CD
Diagnostic yield of PCCE, MREC and US for CD located proximal to the terminal ileum
Time frame: 36 months
Patients reported experience
Patients' subjective experience of discomfort during PCCE, MREC, US and ileocolonoscopy
Time frame: 36 months
Interobserver PCCE
Sensitivity and specificity of PCCE with different reading protocols
Time frame: 36 months
Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow
Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow (Limberg score): Sensitivity, specificity and correlation with endoscopic disease activity
Time frame: 36 months
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