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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Svendborg Hospital | OTHER |
| Skane University Hospital | OTHER |
| Vejle Hospital |
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The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease.
The main question it aims to answer is:
How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations?
Researchers will compare with patients examined with colonoscopy and a small bowel examination.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive diagnostic algorithm | Experimental |
| |
| Traditional work-up | Active Comparator | Colonoscopy and either MRI enterography or small bowel capsule endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panenteric capsule endoscopy | Diagnostic Test | Panenteric capsule endoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic completeness | Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations | Immediately after initial diagnostic procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of pan-enteric CE | Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided | After completion of follow-up (12 months) |
| Additional examinations |
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Inclusion Criteria:
Clinical suspicion of CD*
Age 18-40 years
Signed informed consent
*A clinical suspicion of CD is based on the following definition:
Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either
C-reactive protein (CRP) > 5 mg/L
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)
Prolonged fever (> 37.5 ◦C for more than 2 weeks)
Weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight)
Perianal abscess / fistula
Family history of inflammatory bowel disease.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederik D Thrane, MD | Contact | 0045 79183140 | Frederik.Drejer.Thrane2@rsyd.dk | |
| Michael D Jensen, MD, PhD | Contact | 0045 79183140 | Michael.Dam.Jensen@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Frederik D Thrane, MD | Esbjerg Hospital - University Hospital of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Esbjerg Hospital - University Hospital of Southern Denmark | Recruiting | Esbjerg | 6700 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2024 | Nov 13, 2024 |
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| OTHER |
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| Ileocolonoscopy | Diagnostic Test | Endoscopic examination of the colon and terminal ileum after bowel preparation. |
|
| MRI enterography | Diagnostic Test | MRI of the small bowel |
|
| Small bowel capsule endoscopy | Diagnostic Test | Capsule endoscopy of the small bowel |
|
Need for additional examinations in the two randomization arms
| After completion of follow-up (12 months) |
| Safety | Number of severe adverse events | After completion of follow-up (12 months) |
| Time to diagnosis | Time from referral or first diagnostic procedure to final diagnosis and treatment | After completion of follow-up (12 months) |
| Disease classification and medical treatments | Disease classification and medical treatments in the two randomization arms | After completion of follow-up (12 months) |
| Patient satisfaction | Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score | Immediately after initial diagnostic procedure |
| Costs | Expenditure on diagnostic procedures, treatment and loss of productivity | After completion of follow-up (12 months) |
| Artificial intelligence | Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making | Immediately after initial diagnostic procedure |
| Odense University Hospital | Recruiting | Odense C | 5000 | Denmark |
|
| Odense University Hospital - Svendborg Hospital | Not yet recruiting | Svendborg | 5700 | Denmark |
|
| Lillebaelt Hospital Vejle - University Hospital of Southern Denmark | Recruiting | Vejle | 7100 | Denmark |
|
| Skåne University Hospital | Not yet recruiting | Malmö | 205 02 | Sweden |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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