The goal of this study is to improve the diagnostic work-up of the small bowel in children suspected of IBD or diagnosed with CD and with suspicion of small bowel disease by comparing enteroscopy as gold standard to ultrasonography, Magnetic…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To detect disease activity in the small bowel of children suspected of IBD or
diagnosed with CD with suspicion of small bowel disease.
Secondary outcome
1. To determine sensitivity and specificity of ultrasound, MRI and WCE compared
to enteroscopy with histology in diagnosing IBD.
2. To determine sensitivity and specificity of ultrasound, MRI and WCE compared
to enteroscopy with histology in detection of disease activity in the small
bowel in IBD.
3. To determine the correlation between disease activity in the small bowel
detected by ultrasound, MRI, WCE and enteroscopy with histology with clinical
disease activity (PCDAI).
4. To determine the correlation between disease activity in the small bowel
detected by ultrasound, MRI, WCE and enteroscopy with histology and laboratory
findings (CRP, BSE).
5. To determine patient satisfaction, when undergoing ultrasound, MRI, WCE and
enteroscopy.
6. To assess histology of the small bowel in the biopsies taken for the
presence of Paneth cells, macrophages, dendritic cells, NKT, T and B
lymphocytes and to test immunological cellular response.
Background summary
In pediatric CD, upper gastrointestinal tract involvement occurs frequently.
The small bowel may also be involved, even though the terminal ileum is normal.
In 2004, the ESPGHAN IBD working group developed the Porto criteria, to obtain
uniformity in the work-up and criteria used for diagnosis. Every child
suspected of IBD should undergo esophagogastroduodenoscopy (EGD),
ileocolonoscopy (CS), both with biopsies and (in all cases except in definite
ulcerative colitis) imaging of the small bowel with enteral contrast medium
(x-enteroclysis). However, a drawback of imaging of the small bowel with
enteral contrast medium is the ionizing radiation. Besides, sensitivity to
detect findings consistent with CD is rather low. Alternative examinations for
small bowel imaging are ultrasound, Magnetic Resonance Imaging (MRI),
enteroscopy and wireless capsule endoscopy (WCE).
Study objective
The goal of this study is to improve the diagnostic work-up of the small bowel
in children suspected of IBD or diagnosed with CD and with suspicion of small
bowel disease by comparing enteroscopy as gold standard to ultrasonography,
Magnetic Resonance Imaging (MRI), and WCE.
Study design
Prospective diagnostic study design.
Study burden and risks
Since the capsule can get stuck in patients with stenosis in the gut patients
will undergo MRE and enteroscopy before WCE. Only after exclusion of stenosis
on the MRE by the radiologist and during enteroscopy by the gastroenterologist,
the video capsule will be inserted.
If there is any doubt that the videocapsule has passed the whole bowel, an
X-ray of the abdomen will be performed after a few days (protocol pg. 7-8). The
extra amount of time is minimal since the extra examinations are combined with
the regular examinations.
Dr Molewaterplein 60
3000 CB Rotterdam
Nederland
Dr Molewaterplein 60
3000 CB Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients aged 8-18 years, suspected of IBD who would otherwise be scheduled to undergo an ileocolonoscopy and upper gastrointestinal endoscopy and x-enteroclysis or MRI to confirm or exclude this diagnosis.
Patients aged 8-18 years, diagnosed with CD with suspicion of small bowel disease who would otherwise be scheduled to undergo an ileocolonoscopy and upper gastrointestinal endoscopy and x-enteroclysis or MRI to evaluate small bowel disease.
Exclusion criteria
Pregnancy or lactation.
Inability to tolerate a 25 second breath-hold.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21948.078.08 |