Assesment of small bowel CD activity using the NBI compared to the conventional white light endoscopy, using the single balloon enteroscopy system in patients with known CD and suspected small bowel disease activity.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of NBI enteroscopy with WLE in detection and grading of CD
inflammation in small bowel, using findings on histopathology as the
gold-standard for mucosal inflammation.
Secondary outcome
Correlation of endoscopic findings with clinical findings.
Correlation of endoscopic findings with immunohistochemical analysis of
immunocompetent cells and mRNA levels of proinflammatory cytokines.
Background summary
Crohn*s disease (CD) is a chronic inflammatory disease of the entire
gastrointestinal tract. CD is mainly localised in the ileocecal region (38%),
ileum (27%) and colon (19%). In up to 20% of CD patients, disease activity is
located in the upper gastrointestinal tract, which in great part is not
accessible for standard diagnostic techniques (i.e. gastroduodeno- and
ileocolonoscopy). Small bowel involvement of CD is known as an independent risk
factor for complicated disease. CD patients with small bowel activity more
often need step-up medical treatment and surgical interventions. Timely
detection of small bowel activity of CD might lead to adjustment of therapy to
prevent complications of the disease. Since the introduction of balloon
assisted enteroscopy (BAE) and wireless capsule endoscopy (WCE), endoscopic
visualization of the entire small bowel has become possible and is therefore of
great interest for CD patients. BAE has proven its additional value in known CD
patients with suspected small bowel activity. It was shown that in up to 70% of
patients, small bowel disease activity was found. In 40% of these patients,
this disease activity was not accessible for conventional endoscopy.
Nevertheless, in approximately one third of CD patients with complaints
suspected for small bowel disease activity, no evident signs of inflammation
are found. We hypothesize that in a subset of these patients minor mucosal
inflammation is present, which is not visualized with the current standard
(white light) endoscopic techniques. Leaving this minor mucosal inflammation
undetected and therefore untreated, might result in relapse and complicated CD
These patients could profit from early detection and timely adjustment of
(medical) therapy. To visualize this inflammation, improved techniques for a
better assessment of the grade of inflammation than the conventional white
light endoscopy (WLE) used by enteroscopy are necessary. Narrow band imaging
(NBI) endoscopy is a unique system by the application of narrow band filers for
the light source. This results in different images at distinct levels of the
mucosa and increases the contrast between the epithelial surface and the
subjacent vascular pattern. NBI visualizes the disorganization of the pit
pattern and vascular pattern of the gastrointestinal mucosa in inflammatory and
neoplastic (premalignant and malignant) lesions. NBI is used and proven
accurate for the screening of gastrointestinal and oropharyngeal neoplasms. NBI
can determine the grade of inflammation in patients with ulcerative colitis.
Study objective
Assesment of small bowel CD activity using the NBI compared to the conventional
white light endoscopy, using the single balloon enteroscopy system in patients
with known CD and suspected small bowel disease activity.
Study design
The study is designed as a single center, nonrandomized controlled trial.
Study burden and risks
Nature and extent of the burden: There is minimally extent of the burden by
prolonging the balloon enterocopy with approximately 15 minutes as a result of
visualizing of the small bowel segments with whitelight and NBI separately.
There will be taken more biopsies form the small bowel cause we expect that we
will visualize more abnormaities wit NBI; a maximum of 16 to 24 additional
biopsies will be taken.
Risk: The risk associaiated with participation is very low. We also don't
expect extra risks by taking the biopsies from the small bowel.
Postbus 2040
3000 CA rotterdam
Nederland
Postbus 2040
3000 CA rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Individuals eligible for inclusion are patients with age 18 years or older, with known Crohn's disease or iron deficiency anemia.
Exclusion criteria
Age under 18 years of age.
Medical and psychological contraindications for enteroscopy.
Patients unable or not willing to give informed consent.
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
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28133.078.09 |