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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Sygehus Lillebaelt | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trial participant | Other | All participants undergoes the same diagnostic imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic imaging | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
General criterion
All of the following:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob B Brodersen, MD | Esbjerg Hospital - University Hospital of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydvestjysk sygehus | Esbjerg | DK-6700 | Denmark | |||
| Odense university Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37459054 | Derived | Brodersen JB, Jensen MD, Juel MA, Kjeldsen J, Knudsen T, Rafaelsen SR. Intestinal ultrasound in patients with suspected Crohn's disease - results of a prospective evaluation by trainees. Scand J Gastroenterol. 2023 Jul-Dec;58(12):1405-1411. doi: 10.1080/00365521.2023.2234538. Epub 2023 Jul 17. | |
| 36069336 | Derived |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| 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 |
| Odense |
| DK-5000 |
| Denmark |
| Sygehus Lillebaelt | Vejle | DK-7100 | Denmark |
| Brodersen JB, Knudsen T, Kjeldsen J, Juel MA, Rafaelsen SR, Jensen MD. Diagnostic accuracy of pan-enteric capsule endoscopy and magnetic resonance enterocolonography in suspected Crohn's disease. United European Gastroenterol J. 2022 Nov;10(9):973-982. doi: 10.1002/ueg2.12307. Epub 2022 Sep 7. |
| D007410 | Intestinal Diseases |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |