Facts & Objectives

Gastrointestinal (GI) disorders affect millions of people of all ages.  What is more, inflammatory bowel diseases (IBDs) are a huge healthcare problem in the Western World, with Crohn’s disease affecting 700,000 people in Europe alone.  Research in Crohn’s disease is particularly challenging due to its nature, which complicates a straightforward assessment of the severity. 

The high incidence and prevalence make that IBD are a huge healthcare problem. IBD can begin at any age, but adolescents and young adults between the ages of 15 and 35 are most susceptible. The condition affects both men and women equally. Current evidence suggests that both genetic and environmental factors contribute to the aetiology. IBD are characterized by an inflammation of the bowel wall due to an abnormal response in the body’s defence mechanism. Several types of IBD are distinguished by distinct genetic profiles, different clinicopathological features, including different locations affected within the GI tract, diverse histological patterns of inflammation and the relative importance of various symptoms such as abdominal cramps, diarrhoea, fever and weight loss. For instance, Crohn’s disease can affect any part of the GI tract from mouth to anus whereas ulcerative colitis, another common IBD, is confined to the colon. Also, Crohn’s disease may consist of patches of diseased and healthy tissue, whilst ulcerative colitis usually has a more uniform distribution. Crohn’s disease can also lead to the development of strictures where the diseased bowel becomes narrowed and to fistulae as a result of severe ulcers breaking through the bowel wall to form abnormal connections with other parts of the body such as the bladder or the skin.

Crohn’s disease is characterized by a chronic relapsing and remitting course, i.e. periods of exacerbations are alternated by episodes of diminished disease activity. Accordingly, the mere presence of the disease must be distinguished from active disease, which can occur at varying levels of severity. The changes in disease activity are not necessarily correlated to changes in symptoms. Colonoscopy in combination with the assessment of biopsy samples is considered the reference standard for diagnosis of IBD. However, the procedure is invasive and requires extensive bowel preparation which is poorly tolerated by most patients. Also, the technique primarily gives information on superficial abnormalities (limited to direct visual inspection of the bowel lining or tissue samples from the inner bowel layers only), without much information on the intestinal wall or extra-intestinal disease, both of which are very important in Crohn’s disease. As a consequence, radiological imaging techniques have become important for evaluating disease activity in Crohn’s disease by providing information about the bowel lumen, bowel wall and extra enteric soft tissues.

Grading of Crohn’s disease severity is important to determine treatment strategy and to quantify the response to treatment. Ideally, an activity score should be objective, reproducible, quantifiable, non-invasive and comprehensive. In clinical practice, this assessment can be made by the Crohn’s Disease Activity Index (CDAI), laboratory investigations and/or endoscopy (scored in Crohn’s Disease Endoscopic Index of Severity (CDEIS). However, none of these methods are infallible. The CDAI is a clinical index that incorporates subjective elements and therefore partly reflects patients’ perception of disease severity. Alternatively, blood markers can be unchanged in the presence of active disease. The CDEIS score requires endoscopy, which is considered a very invasive procedure by most patients. Moreover, none of these indices include aspects of transmural and extra intestinal disease activity. Recently, D’Haens proposed a scoring system for histological abnormalities in biopsy specimens, but that measure focuses solely on microscopic aspects of Crohn’s disease. The table below summarizes the limitations for the described disease indices. The complex nature of Crohn’s disease hinders the development of an improved index. VIGOR++ aims to set a new standard by delivering a disease index that fulfils all the needs. A clever combination of existing image analysis and pattern recognition drives its development.

Synopsis of Crohn’s disease indices.

Index\requirement:

Objective

Reproducible

Quantifiable

Noninvasive

Comprehensive

CDAI

-
+/-
-
+
-

CDEIS

+/-
+
-
--
-

D’Haens

+/-
+
-
--
-

VIGOR++

+
+
+
+
+

Objectives

The VIGOR++ project is about research and development of ICT tools for the analysis, modelling and simulation of human physiology and disease processes of the GI tract. It will use the ICT tools to build patient-specific computer models to sustain personalised healthcare. Such tools are widely favoured by physicians and other medical disciplines for improved diagnosis and follow-up. The uniqueness of our approach is that it enables quantitative assessment of diseases of the GI tract. Consequently, it is expected that the tools will be very valuable to, for instance, pharmaceutical companies: clinical trials can be much more efficient by having accurate, quantitative descriptors of therapy effect and so reduce the high cost.

In VIGOR++ Crohn’s disease patients are the starting point as well as the end point of a working cycle. Multiscale data acquisition including laboratory, MRI, colonoscopy and microscopy data from these patients supports the development of integrated ICT tools. These tools include a normal representation of the GI tract that facilitates detection of abnormalities, ability to grade disease severity, and influence clinical disease management. The clinical benefit will demonstrated in a study in which the tools are assessed regarding the performance to predict Crohn’s disease status: application and validation. Moreover, a preliminary study will be performed in which the effect of therapy will be established. Ultimately, it is expected that the tools can be readily commercialised which we consider a crucial ingredient to dissemination. 

The overall project objectives are summarised below:

a. Adaptation of existing image analysis algorithms to accurately measure descriptive properties of GI wall tissue.
b. Creation of patient specific instruments to quantitatively assess the status of Crohn’s disease.
c. Effective visualisation of the versatile aspects of the GI tract model.
d. Perform rigorous testing to guarantee that a clinically usable system is created.
e. Establish a new care pathway for accurate, non-invasive and cost-effective examination of the GI tract for Crohn’s disease.
f. Disseminate generated knowledge and ICT tools by actively engaging fellow academic disciplines, industry and IBD patient associations across Europe.
g. Identify opportunities for commercial exploitation of developed technology.