Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease (ANDI-3)

Esbjerg Hospital - University Hospital of Southern Denmark

Status

Enrolling

Conditions

Crohn's Disease

Treatments

Diagnostic Test: Small bowel capsule endoscopy

Diagnostic Test: Ileocolonoscopy

Diagnostic Test: MRI enterography

Diagnostic Test: Panenteric capsule endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT06882993

24/50881

Details and patient eligibility

About

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

Enrollment

165 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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