Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Esbjerg Hospital - University Hospital of Southern Denmark
RECRUITING
Esbjerg
Odense University Hospital
RECRUITING
Odense C
Odense University Hospital - Svendborg Hospital
NOT_YET_RECRUITING
Svendborg
Lillebaelt Hospital Vejle - University Hospital of Southern Denmark
RECRUITING
Vejle
Sweden
Skåne University Hospital
NOT_YET_RECRUITING
Malmo
Contact Information
Primary
Frederik D Thrane, MD
Frederik.Drejer.Thrane2@rsyd.dk
0045 79183140
Backup
Michael D Jensen, MD, PhD
Michael.Dam.Jensen@rsyd.dk
0045 79183140
Time Frame
Start Date: 2025-02-26
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 165
Treatments
Experimental: Minimally invasive diagnostic algorithm
Active_comparator: Traditional work-up
Colonoscopy and either MRI enterography or small bowel capsule endoscopy
Sponsors
Leads: Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: Odense University Hospital, Svendborg Hospital, Vejle Hospital, Skane University Hospital

This content was sourced from clinicaltrials.gov