Clinical trial NCT03134586: Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease
Official title: A Comparative Study of the Diagnostic Validity of Ultrasound, Magnetic Resonance Imaging and Capsule Endoscopy of Both the Small and Large Intestine in Suspected Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Keywords: Capsule endoscopy
Crohn's disease
Magnetic resonance enterography
Ileocolonoscopy
Bowel Ultrasound
diagnostic imaging
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Sygehus Lillebaelt
First posted: 2017-05-01
Enrollment: 153
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity in patients with suspected CD compared to the traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality

Detailed description: This is a prospective, blinded, multicenter study of the diagnostic validity, inter-observer agreement, image quality and subjective experience of discomfort with PCCE, MREC and US in patients with suspected CD. Ileocolonoscopy serves as the diagnostic gold standard. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, PCCE, MREC and US. All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing PCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities.

Eligibility criteria: Inclusion Criteria:

General criterion

All of the following:

* Clinical suspicion of CD
* Age \> 15 years
* Negative serologic markers for celiac disease, negative stool culture (or polymerase chain reaction) for pathogenic bacteria and a negative microscopy for intestinal parasites
* Fecal calprotectin \> 50 mg/kg
* Signed informed consent

Clinical criterion Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) associated with one or more of the following findings: (1) C-reactive protein (CRP) \>5 mg/L, (2) 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), (3) prolonged fever (\> 37.5 C for more than 2 weeks), (5) weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight), (6) perianal abscess/fistula, or (7) a family history of inflammatory bowel disease.

Exclusion Criteria:

* Acute bowel obstruction
* Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose Aspirin (≤ 150 mg per day)
* Pregnancy or lactation
* Alcohol or drug abuse
* Known gastrointestinal disorder other than inflammatory bowel disease
* Renal failure defined by a plasma-creatinine above the normal reference range
* Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes MREC
* Interpreter required or inability to understand the oral and written information
* Colonoscopy contraindicated, performed within 3 months or unwillingness to go through colonoscopy

Primary outcomes:
measure: Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD
timeFrame: 36 months
measure: Correlation of disease severity
timeFrame: 36 months
measure: Inter-observer agreement
timeFrame: 36 months
Secondary outcomes:
measure: Diagnostic yield of proximal CD
timeFrame: 36 months
measure: Patients reported experience
timeFrame: 36 months
measure: Interobserver PCCE
timeFrame: 36 months
measure: Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow
timeFrame: 36 months
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvestjysk sygehus
city: Odense
country: Denmark
facility: Odense university Hospital
city: Vejle
country: Denmark
facility: Sygehus Lillebaelt
Study officials:
affiliation: Esbjerg Hospital - University Hospital of Southern Denmark
name: Jacob B Brodersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brodersen JB, Knudsen T, Kjeldsen J, Juel MA, Rafaelsen SR, Jensen MD. Diagnostic accuracy of pan-enteric capsule endoscopy and magnetic resonance enterocolonography in suspected Crohn's disease. United European Gastroenterol J. 2022 Nov;10(9):973-982. doi: 10.1002/ueg2.12307. Epub 2022 Sep 7.