Short summary

Crohn's disease (CD) is a chronic ulcerative disorder located throughout the gastrointestinal tract. CD has a strong tendency to relapse after remission has been achieved with medical treatment or surgical resection. Patients are treated with immunosuppressive drugs, and improved non-invasive modalities for monitoring the effect of treatment are warranted. The aim of this study is to evaluate the applicability of panenteric capsule endoscopy, MR enterocolonography and bowel ultrasound for diagnosing ulcer healing after medical treatment in patients with symptomatic CD compared to the current gold standard (ileocolonoscopy).

Rationale

Crohn's disease (CD) belongs to the group of chronic inflammatory bowel diseases. The etiology is unknown, but CD is thought to arise from a dysregulated interaction between the gut microbiome and the mucosal immune system in a genetically predisposed individual. Typically, CD has a segmental distribution, and the entire gastrointestinal tract may be involved - from mouth to anus. Clinically, CD is characterized by recurrent disease activity and a strong tendency to relapse after remission has been achieved with medical treatment or surgical resection. 

Ileocolonoscopy is the accepted gold standard for monitoring disease activity in patients with known CD. However, the examination is invasive, associated with patient discomfort and a small risk of colonic perforation (< 1 per 1,000 colonoscopies). 

In recent years, technological advances have improved non-invasive modalities for diagnosing and monitoring CD. The primary modalities are magnetic resonance imaging enterocolonography (MREC), ultrasound (US), and capsule endoscopy (CE). All modalities are able to visualize both the small intestine and colon in one examination. How to apply these modalities in clinical practice, and whether disease activity in known CD and treatment response can be diagnosed without performing ileocolonoscopy is still unknown.

The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known CD.

1. Comparing imaging modalities:

The applicability of CE, MREC and US for diagnosing ulcer healing after medical treatment in patients with symptomatic CD compared to ileocolonoscopy.

2. Treatment induced bowel wall alterations visualized with US:

A non-blinded study of bowel wall changes detected with repeated US examination during medical treatment of known CD.

Description of the cohort

Patients with symptomatic CD are recruited from the gastroenterology outpatient clinics and endoscopy units. Patients who meet the following criteria are eligible for inclusion:

- An established diagnosis of CD 

- Age > 18 years

- Ileocolonoscopy showing active CD (SES-CD ? 3)

- Clinically active CD (Harvey-Bradshaw Index ? 5 or Crohn's Disease Activity Index ? 150)

- Clinical indication for medical treatment with corticosteroids or biological therapy

- Signed informed consent

Data and biological material

This is a prospective, blinded, multicenter study of the diagnostic accuracy of CE, MREC and US for diagnosing ulcer healing in patients with endoscopically active CD and a clinical indication for medical treatment. Collected data are:

- Background information (demographics, clinical data)

- Symptom score

- Inflammatory markers (blood and stool)

- Findings at MREC, US, CE and ileocolonoscopy

Collaborating researchers and departments

Department of Internal Medicine, Lillebaelt Hospital Vejle

• Consultant, PhD Michael Dam Jensen
• Staff specialist Mie Agerbæk Juel

Department of Medical Gastroenterology, Odense University Hospital

• Professor, PhD Jens Kjeldsen

Department of Internal Medicine, Hospital of Southern Jutland

• Staff specialist, Jacob Broder Brodersen
• Consultant, DMSc, PhD Torben Knudsen

Department of Radiology, Lillebaelt Hospital Vejle

• Professor, DMSc Søren Rafael Rafaelsen

Publications associated with the project