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.
Conditions
Interventions
1. MRI enteroclysis
2. Double ballon endoscopy
3. Videocapsule
Sponsors
Schering AG, Christiane Pering, M.D.
Siemens Nederland, Ronald Prinsze
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of >18 and < 75 years 2. One of the following patient groups: 2.1 Patients with suspected Crohn’s disease 2.2 Patients with Crohn’s disease, in need of visualization of the small bowel because of suspected disease activity. 2.3 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
Exclusion criteria: 1. Patients with suspected intra-abdominal abscess 2. Abdominal surgery in the 6 weeks prior to inclusion 3. Patients with clinical suspicion of high grade small bowel obstruction 4. Pregnancy 5. Breastfeeding 6. Inability to swallow the video capsule 7. Presence of a pacemaker or cardioversion device 8. Patients with a history of contrast media reaction and history of allergy (esp. asthma) 9. Severe concomitant disease with limited life expectancy 10. A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. For patients with known or suspected Crohn’s disease of the small bowel, a comparison will be made for prevalence, location, severity of inflammatory lesions, and complications such as formation of stenotic lesions. For patients with gastrointestinal blood loss, the techniques will be compared for prevalence and location of bleeding foci and characters of the lesion. The findings at the double balloon endoscopy will be used as the gold standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| patients’ appreciation of the different diagnostic methods. This will be analysed by means of a questionnaire. Patients will be asked to repeatedly fill out the same questionnaire, 24 hours before and after each examination and 5 weeks after all the examinations. | — |
Contacts
Public ContactB.M. Wiarda
Medical Center Alkmaar P.O.Box 500
Outcome results
None listed