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
Clinical suspicion of CD*
Age 18-40 years
Signed informed consent
Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either
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
Parallel
Panenteric capsule endoscopy
Diagnostic testPanenteric capsule endoscopy
Ileocolonoscopy
Diagnostic testEndoscopic examination of the colon and terminal ileum after bowel preparation.
MRI enterography
Diagnostic testMRI of the small bowel
Small bowel capsule endoscopy
Diagnostic testCapsule endoscopy of the small bowel
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
Feasibility of pan-enteric CE
Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided
Additional examinations
Need for additional examinations in the two randomization arms
Safety
Number of severe adverse events
Time to diagnosis
Time from referral or first diagnostic procedure to final diagnosis and treatment
Click on the lead sponsor to view all of their trials.
Esbjerg Hospital - University Hospital of Southern Denmark
Lead sponsor
Odense University Hospital
Collaborator
Svendborg Hospital
Collaborator
Skane University Hospital
Collaborator
Vejle Hospital
Collaborator