Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease (ANDI)

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

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

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Diagnostic imaging

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark, DK-6700
    • Sydvestjysk Sygehus
  • Odense, Denmark, DK-5000
    • Odense University Hospital
  • Vejle, Denmark, DK-7100
    • Sygehus Lillebaelt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: trial participant; All participants undergoes the same diagnostic imaging	Other: Diagnostic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Correlation of disease severity	Correlation of disease severity assessed with PCCE, MREC, US and ileocolonoscopy	36 months
Inter-observer agreement	Inter-observer agreement with PCCE, MREC, US and ileocolonoscopy	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield of proximal CD	Diagnostic yield of PCCE, MREC and US for CD located proximal to the terminal ileum	36 months
Patients reported experience	Patients' subjective experience of discomfort during PCCE, MREC, US and ileocolonoscopy	36 months
Interobserver PCCE	Sensitivity and specificity of PCCE with different reading protocols	36 months
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

Collaborators and Investigators

• Sponsor: Hospital of South West Jutland
• Collaborators: Odense University Hospital; Sygehus Lillebaelt
• Investigators: Principal Investigator: Jacob B Brodersen, MD, Hospital of South West Jutland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Crohn's disease; Capsule endoscopy; diagnostic imaging; Magnetic resonance enterography; Ileocolonoscopy; Bowel Ultrasound
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: ANDI 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No