Assessment of the performance of the new generation Pillcam colon capsule (PCCE 2) in Crohn's disease: an exploratory study.

The goals of treatment in Crohn's disease have evolved in recent years from
symptom control to healing of mucosal lesions, usually visualized by
endoscopies. Potent treatment combinations, including anti-TNF agents and
thiopurines, have made restoration of mucosal integrity attainable in a
significant proportion of patients. Moreover, biologic therapies were shown to
be more effective in patients that had visible ulcers on videoendoscopy than in
patients without such lesions. This means that clinicians are recommended to
check for the presence of ulcers before they embark on biologic therapy.
Finally, endoscopic follow-up of treatment effects in Crohn's disease has
entered routine practice.

However, endoscopic procedures are time consuming, unpleasant and expensive.
Surrogate markers for the severity of inflammation such as faecal calprotectine
are under investigation. Magnetic Resonance Enterocolonography (MRE) was shown
to nicely parallel the severity of inflammation, but also this test is
expensive and time consuming.

The development of a simple alternative to optical colonoscopy to assess
mucosal inflammation in patients with Crohn's disease would therefore be of
extreme importance. A reliable pill-cam examination is high on the priority
list of potential options.

In this study we will explore the examination with the second generation
Pillcam capsule (PCCE 2) in patients with Crohn's disease. Crohn's patients
with symptomps that need an endoscopy according to the treating physisian,
will be asked to participate in this trial. They will both have a colonoscopy
as a Pillcam examination in 1 day. The recordings of the PCCE 2 Pillcam will be
compared with the findings of the colonoscopy.

An explorative open label study with 80 patients in 4 sites.

During the screening period an amount of 30 cc blood will be taken from the
patient and the fecal Calprotectin will be measured once. Besides the patient
will be asked to keep a diary during 7 days for the CDAI score.

Before both the Pillcam procedure and the colonoscopy the bowel needs to be
clean. Therefore the patient needs to:
* follow a clear diet the day prior to the tests
* drink 2 litres Colopeg the evening before the tests
* drink 2 litres Colopeg the morning for the tests

After swallowing the PCCE 2 capsule, the patient will have to drink 30 cc of
Phosphosoda.

A cohort of 20 patients that are treated with anti-TNF, will be invited to
undergo a second colonoscopy and Pillcam procedure after 8-12 weeks of
treatment.

All participating patients will receive telephone calls from the study
coordinator at 1 day, 1 week and 1 month after the procedures. The study
coordinator will ask for Adverse Events.

A potential risk of the Pillcam examination is retention of the capsule in the
bowel. In patients without (suspicion of) bowel stenosis this risk is
negligible. When a stenosis is suspected, the patient will have to swallow a
patency capsule, which has the same dimensions as the PCCE 2 capsule. When the
patency capsule got stucked it will dissolcve within 36 hours after intake.

During colonoscopy patients will receive intra-venous sedative agents or a
short comlete anaesthesia.
A colonoscopy is relative save. There is a small risk of complications (1 in
500 procedures), such as bleeding or perforation.