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 symptoms that need an endoscopy according to the treating physisian, will be asked to…
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Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Examine sensitivity and specificity of the PCCE2(Pillcam) to detect mucosal
healing in Crohn's patients before and after treatment with Infliximab or
Adalimumab or Vedolizumab.
Secondary outcome
1. Safety and tolerability of the preparation procedure and the Pillcam
examination
2. Determine inter-observer variability by serial readings of Pillcam
recordings
Background summary
The goals of treatment in Crohn's disease have evolved in recent years from
symptom control to healing of mucosal lesions, usually visualized by endoscopy.
Potent therapeutic agents, such as anti-TNF agents, have made restoration of
mucosal integrity attainable in a significant proportion of patients. Moreover,
anti-TNF therapy was shown to be more effective in patients that had visible
ulcers on endoscopy than in patients without such lesions. This means that
clinicians are recommended to check for the presence of ulcers before they
embark on biological therapy. Finally, endoscopic evaluation of treatment
effects in Crohn's disease has entered routine practice.
However, endoscopic procedures are time consuming, invasive and unpleasant for
the patient. Surrogate markers for the severity of inflammation such as faecal
calprotectine are under investigation. Magnetic Resonance Enterocolonography
(MRE) was shown to nicely parallel with the severity of inflammation seen at
endoscopy, but also this diagnostic tool 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 Pillcam examination is high on the priority list
of potential options.
Recently, a multicenter study was performed that assessed safety and feasibilty
of PCCE-2 in evaluating the severity of mucosal inflammation in patients with
ileocolonic Crohn's disease (1). Substantial agreement was found between PCCE-2
and conventional colonoscopy for the assessment of mucosal disease activity.
Moreover, PCCE-2 was better tolerated than coloscopy in these patients.
Study objective
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 symptoms that need an endoscopy according to the treating
physisian, will be asked to participate in this trial. They will have two
Pillcam examinations. The two Pillcam procedures will be compared to detect
mucosal healing.in Crohn's patients before and after treatment with Infliximab
or Adalimumab or Vedolizumab.
Study design
A prospective study with 20 active Crohn's disease patients in 2 sites.
Study burden and risks
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 the Pillcam procedure the bowel needs to be clean. Therefore the patient
needs to
* follow a clear diet the day prior to the tests
* drink 1 litre Moviprep the evening before the tests
* drink 1 litre Moviprep the morning for the tests, then 1h break.
All participating patients will receive telephone calls from the study
coordinator at 1 day, 1 week and 1 month after the Pillcam 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 dissolve within 36 hours after intake.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Active ileocolonic Crohn's disease with CDAI > 150
Elevated faecal calprotectin >250 ug/g and /or increased CRP levels(>5mg/l)
and/ or endoscopy showing ulcerations <3 months prior to screening without any
change in treatment, regardless of biomarkers.
Abdominal imaging clinically indicated in order to determine disease activity
before embarking on anti-TNF or vedolizumab treatment
Exclusion criteria
Any contraindication for colon capsule examination including swallowing
disorders, severe congestive heart failure, renal insufficiency or co-morbities
contraindicating these procedures.
More than 1 bowel resection for CD
Previous subtotal or total colectomy
Active (draining) fistulas
Known small bowel strictures
Short bowel syndrome or stoma
High suspicion of small bowel strictures.
Pacemaker or ICD
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55599.018.16 |
| OMON | NL-OMON22197 |