Crohn's Disease
Conditions
Keywords
capsule endoscopy, panenteric capsule endoscopy, Crohn's disease, inflammatory bowel disease
Brief summary
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: * Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination * Have their electronic medical records checked to see if a diagnosis has been made * Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found
Interventions
DIAGNOSTIC_TESTPanenteric capsule endoscopy
Panenteric capsule endoscopy
DIAGNOSTIC_TESTIleocolonoscopy
Endoscopic examination of the colon and terminal ileum after bowel preparation.
DIAGNOSTIC_TESTMRI enterography
MRI of the small bowel
DIAGNOSTIC_TESTSmall bowel capsule endoscopy
Capsule endoscopy of the small bowel
Sponsors
Esbjerg Hospital - University Hospital of Southern Denmark
Odense University Hospital
Svendborg Hospital
Skane University Hospital
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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 * fecal calprotectin ≥ 200 mg/kg or * fecal calprotectin ≥ 50 mg/kg plus one or more of the following findings: * 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
* Previous intestinal resection * Positive serologic markers for celiac disease * Positive stool polymerase chain reaction for pathogenic bacteria * Positive stool polymerase chain reaction for intestinal parasites * Suspected or established acute bowel obstruction (ileus) * Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion, except low-dose, prophylactic acetylsalicylic acid (≤ 150 mg per day) * Intake of opioid or opioid-like medications ≤ 1 week before inclusion * Pregnancy or lactation * Inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse * Known gastrointestinal disorder other than functional gastrointestinal disorders * Renal failure defined by a plasma-creatinine above the normal reference range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic completeness | Immediately after initial diagnostic procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of pan-enteric CE | After completion of follow-up (12 months) | Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided |
| Additional examinations | After completion of follow-up (12 months) | Need for additional examinations in the two randomization arms |
| Safety | After completion of follow-up (12 months) | Number of severe adverse events |
| Time to diagnosis | After completion of follow-up (12 months) | Time from referral or first diagnostic procedure to final diagnosis and treatment |
| Disease classification and medical treatments | After completion of follow-up (12 months) | Disease classification and medical treatments in the two randomization arms |
| Patient satisfaction | Immediately after initial diagnostic procedure | Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score |
| Artificial intelligence | Immediately after initial diagnostic procedure | Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making |
| Costs | After completion of follow-up (12 months) | Expenditure on diagnostic procedures, treatment and loss of productivity |
Countries
Denmark, Sweden
Contacts
CONTACTFrederik D Thrane, MD
CONTACTMichael D Jensen, MD, PhD
PRINCIPAL_INVESTIGATORFrederik D Thrane, MD
Esbjerg Hospital - University Hospital of Southern Denmark
Outcome results
None listed