Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Comparative Study of the Diagnostic Validity of Ultrasound, Magnetic Resonance Imaging and Capsule Endoscopy of Both the Small and Large Intestine in Suspected Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: Diagnostic imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: trial participant<br>All participants undergoes the same diagnostic imaging | Other: Diagnostic imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 36 months | 
| Correlation of disease severity | Correlation of disease severity assessed with PCCE, MREC, US and ileocolonoscopy | 36 months | 
| Inter-observer agreement | Inter-observer agreement with PCCE, MREC, US and ileocolonoscopy | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of proximal CD | Diagnostic yield of PCCE, MREC and US for CD located proximal to the terminal ileum | 36 months | 
| Patients reported experience | Patients' subjective experience of discomfort during PCCE, MREC, US and ileocolonoscopy | 36 months | 
| Interobserver PCCE | Sensitivity and specificity of PCCE with different reading protocols | 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 | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capsule endoscopy, Crohn's disease, Magnetic resonance enterography, Ileocolonoscopy, Bowel Ultrasound, diagnostic imaging