Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

Not Applicable

Completed

• Conditions: Crohn Disease
• Interventions: Other: Diagnostic imaging

• Registration Number: NCT03134586
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-05-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-10-23
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
trial participant	Diagnostic imaging	All participants undergoes the same diagnostic imaging

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD	36 months	Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD located in the terminal ileum and colon (per patient \& per segment). Ileocolonoscopy serves as gold standard
Correlation of disease severity	36 months	Correlation of disease severity assessed with PCCE, MREC, US and ileocolonoscopy
Inter-observer agreement	36 months	Inter-observer agreement with PCCE, MREC, US and ileocolonoscopy

Secondary Outcome Measures

Name	Time	Method
Diagnostic yield of proximal CD	36 months	Diagnostic yield of PCCE, MREC and US for CD located proximal to the terminal ileum
Patients reported experience	36 months	Patients' subjective experience of discomfort during PCCE, MREC, US and ileocolonoscopy
Interobserver PCCE	36 months	Sensitivity and specificity of PCCE with different reading protocols
Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow	36 months	Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow (Limberg score): Sensitivity, specificity and correlation with endoscopic disease activity

Trial Locations

Locations (3)

Sydvestjysk sygehus; 🇩🇰 Esbjerg, Denmark

Odense university Hospital; 🇩🇰 Odense, Denmark

Sygehus Lillebaelt; 🇩🇰 Vejle, Denmark