Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Panenteric capsule endoscopy, Ileocolonoscopy, MRI enterography, Small bowel capsule endoscopy.
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 test Panenteric capsule endoscopy
Panenteric capsule endoscopy - Diagnostic test Ileocolonoscopy
Endoscopic examination of the colon and terminal ileum after bowel preparation. - Diagnostic test MRI enterography
MRI of the small bowel - Diagnostic test Small bowel capsule endoscopy
Capsule endoscopy of the small bowel
Primary outcome measures
- Diagnostic completeness [Time frame: Immediately after initial diagnostic procedure]
Secondary outcome measures (8)
- Feasibility of pan-enteric CE [Time frame: After completion of follow-up (12 months)]
- Additional examinations [Time frame: After completion of follow-up (12 months)]
- Safety [Time frame: After completion of follow-up (12 months)]
- Time to diagnosis [Time frame: After completion of follow-up (12 months)]
- Disease classification and medical treatments [Time frame: After completion of follow-up (12 months)]
- Patient satisfaction [Time frame: Immediately after initial diagnostic procedure]
- Costs [Time frame: After completion of follow-up (12 months)]
- Artificial intelligence [Time frame: Immediately after initial diagnostic procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Denmark · 4 centers
- Esbjerg Hospital - University Hospital of Southern Denmark — Esbjerg
- Odense University Hospital — Odense C
- Odense University Hospital - Svendborg Hospital — Svendborg
- Lillebaelt Hospital Vejle - University Hospital of Southern Denmark — Vejle
Sweden · 1 center
- Skåne University Hospital — Malmö
Identifiers
NCT: NCT06882993 · 24/50881