Comparison of two new techniques for detection of small bowel pathology: MR enteroclysis and videocapsule enteroscopy with double-balloon enteroscopy with respect to diagnostic yield, accuracy of findings, and patient preference.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
diagnostic yield, including location and nature of lesions. The pathologic
findings in the small bowel of the different diagnostic methods will be
correlated with each other to analyse location and nature of lesions. This will
assessed in two populations:
1. Patients with known or suspected Crohn*s disease. The findings of the two
techniques will be compared to the double balloon endoscopy on these items:
location, severity of Crohn*s activity, stenosis and complications
2. Patients with signs of chronic or repeated gastrointestinal bleeding with
negative gastroscopy and colonoscopy. The findings of the two techniques will
be compared to the double balloon endoscopy on these items: location of
bleeding focus and characters of the lesion. The findings of the double balloon
endoscopy will be used as the gold standard.
Secondary outcome
Patients* appreciation of the different diagnostic methods. This will be
analysed by means of a questionnaire. The specific questions of each
examination will be filled in before all examinations, 24 hours after the
specific examination and 5 weeks after all the examinations.
Background summary
So far there has been no study that compares videocapsule endoscopy and MR
enteroclysis for common small bowel diseases and especially not with the
improved reference standard double ballon endoscopy. Such a comparison is
highly needed to select appropriate techniques for individual patients. Because
the double balloon endoscopy is in accordance with standard endoscopy, it can
be used as a gold standard method.
Study objective
Comparison of two new techniques for detection of small bowel pathology: MR
enteroclysis and videocapsule enteroscopy with double-balloon enteroscopy with
respect to diagnostic yield, accuracy of findings, and patient preference.
Study design
This will be a prospective study comparing two imaging techniques. MR
enteroclysis will be performed at the department of Radiology of the Medical
Centre Alkmaar. The double-balloon enteroscopy and videocapsule will be
performed at the department of Gastroenterology of the Medical Centre Alkmaar
and the department of Gastroenterology and Hepatology of the Erasmus Medical
Centre Rotterdam.
Intervention
MR enteroclyse, dubbel ballon endoscopie, videocapsule
Study burden and risks
MR enteroclysis: The dosis radiation received in order to place the nasogastric
tube is very small (less than one X-ray of the Thorax). The sound produced by
the MRI is muffled by a headphone which can also produce music. The contrast
agent administered, hardly ever causes an allergic reaction. To reduce the
peristalsis of the small bowel the medicine and the contrast agent are
administered at the same time. This medicine can be of influence on eye
muscles, as a result of which sight will be blurred for a short time. It is
therefore advised not to drive a car directly after examination. After
examination the stool can be watery.
Videocapsule: While swallowing, the videocapsule does not cause any side
effects. If stenosis of the bowel is suspected, a test capsule is swallowed,
which can fall apart in the small bowel.
Double-balloon endoscopy: Because of the anaestatic you will not be aware of
the examination and possible pain will be suppressed. Almost all of the small
bowel can be visualized internally, and in case of abnormalities a piece of
tissue can be biopsied. In general an endoscopy has few side-effects. The
chance of complications as a result of the endoscopy is less than 1 per 1000
endoscopies. Local anaestatic can sometimes cause choking or a reflux resulting
in pneumonia. This is why it is important to remain in the so-called stabile
lying on one's side. Apart from this there is a risk of bleeding during the
taking of biopsies.
Wilhelminalaan 12
1815 JD Alkmaar
Nederland
Wilhelminalaan 12
1815 JD Alkmaar
Nederland
Listed location countries
Age
Inclusion criteria
1. Patients of >18 and < 75 years
2. One of the following patient groups:
a. Patients with suspected Crohn*s disease
b. Patients with Crohn*s disease, in need of visualization of the small bowel because of suspected disease activity.
c. Patients with signs of chronic or repeated gastrointestinal bleeding with negative gastroscopy and colonoscopy
3. Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
Exclusion criteria
Patients will be excluded in case of:
- Abdominal surgery in the 6 weeks prior to inclusion
- Pregnancy
- Breastfeeding
- Inability to swallow the video capsule
- Presence of a pacemaker or cardioversion device
- Severe concomitant disease with limited life expectancy
- A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
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 | NL11250.094.06 |