Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

Crohn Disease Clinical Trial

— ANDI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134586
• Other study ID #: ANDI 1
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: October 23, 2020

Study information

• Verified date: October 2022
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 23, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• Diagnostic imaging

Locations

Country	Name	City	State
Denmark	Sydvestjysk sygehus	Esbjerg
Denmark	Odense university Hospital	Odense
Denmark	Sygehus Lillebaelt	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
Hospital of South West Jutland	Odense University Hospital, Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD	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	36 months
Primary	Correlation of disease severity	Correlation of disease severity assessed with PCCE, MREC, US and ileocolonoscopy	36 months
Primary	Inter-observer agreement	Inter-observer agreement with PCCE, MREC, US and ileocolonoscopy	36 months
Secondary	Diagnostic yield of proximal CD	Diagnostic yield of PCCE, MREC and US for CD located proximal to the terminal ileum	36 months
Secondary	Patients reported experience	Patients' subjective experience of discomfort during PCCE, MREC, US and ileocolonoscopy	36 months
Secondary	Interobserver PCCE	Sensitivity and specificity of PCCE with different reading protocols	36 months
Secondary	Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow	Utility of diffusion weighed magnetic resonance imaging (dw-MREC) and US Doppler flow (Limberg score): Sensitivity, specificity and correlation with endoscopic disease activity	36 months