Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease
Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease
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.
Inclusion Criteria:

 General criterion

 All of the following:

 -  Clinical suspicion of CD

 -  Age > 15 years

 -  Negative serologic markers for celiac disease, negative stool culture (or polymerase
 chain reaction) for pathogenic bacteria and a negative microscopy for intestinal
 parasites

 -  Fecal calprotectin > 50 mg/kg

 -  Signed informed consent

 Clinical criterion Diarrhea and/or abdominal pain for more than 1 month (or repeated
 episodes of diarrhea and/or abdominal pain) associated with one or more of the following
 findings: (1) C-reactive protein (CRP) >5 mg/L, (2) thrombocytosis (> 400 x 109/L), anemia
 (hemoglobin < 7.0 mmol/L for women and < 8.0 mmol /L for men or a decrease > 0.5 mmol/L
 compared to the usual level), (3) prolonged fever (> 37.5 C for more than 2 weeks), (5)
 weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight), (6) perianal
 abscess/fistula, or (7) a family history of inflammatory bowel disease.

 Exclusion Criteria:

 -  Acute bowel obstruction

 -  Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except
 prophylactic treatment with low dose Aspirin (≤ 150 mg per day)

 -  Pregnancy or lactation

 -  Alcohol or drug abuse

 -  Known gastrointestinal disorder other than inflammatory bowel disease

 -  Renal failure defined by a plasma-creatinine above the normal reference range

 -  Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes
 MREC

 -  Interpreter required or inability to understand the oral and written information

 -  Colonoscopy contraindicated, performed within 3 months or unwillingness to go through
 colonoscopy