The COMRADE study.|
|- candidate number||2233|
|- NTR Number||NTR774|
|- Date ISRCTN created||28-dec-2006|
|- date ISRCTN requested||18-dec-2006|
|- Date Registered NTR||5-sep-2006|
|- Secondary IDs||0503 |
|- Public Title||The COMRADE study.|
|- Scientific Title||Small bowel imaging COmparing MR Enteroclysis and Video CApsule with Double-Balloon Endoscopy; the COMRADE study.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Small bowel pathology|
|- 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||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
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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-okt-2006|
|- planned closingdate||1-jun-2009|
|- Target number of participants||80|
|- Interventions||1. MRI enteroclysis|
2. Double ballon endoscopy
|- 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. 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 outcome||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. |
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||M.D. B.M. Wiarda|
|- CONTACT for SCIENTIFIC QUERIES||M.D. B.M. Wiarda|
|- Sponsor/Initiator ||Schering AG, Christiane Pering, M.D., Siemens Nederland, Ronald Prinsze |
(Source(s) of Monetary or Material Support)
|- Publications||1. Nolan DJG, N.C. Crohn's disease of the small intestine: a review of the radiological appearances in 100 consecutive patients examined by a barium infusion technique. Clin Radiol 1980;31:597-603.|
2. Gourtsoyiannis N, Papanikolaou, N., Grammatikakis, J., Papamastorakis, G., Prassopoulos, P., Roussomoustakaki, M. Assessment of Crohn's disease activity in the small bowel with MR and conventional enteroclysis: preliminary results. Eur Radiol 2004;14:1017-1024.
3. Gourtsoyiannis N, Papanikolaou N, Grammatikakis J, Maris T, Prassopoulos P. MR enteroclysis protocol optimization: comparison between 3D FLASH with fat saturation after intravenous gadolinium injection and true FISP sequences. Eur Radiol 2001;11:908-13.
4. Umschaden HW, Gasser J. MR enteroclysis. Radiol Clin North Am 2003;41:231-48.
5. Prassopoulos P, Papanikolaou N, Grammatikakis J, Rousomoustakaki M, Maris T, Gourtsoyiannis N. MR enteroclysis imaging of Crohn disease. Radiographics 2001;21 Spec No:S161-72.
6. Gourtsoyiannis N, Papanikolaou N, Grammatikakis J, Prassopoulos P. MR enteroclysis: technical considerations and clinical applications. Eur Radiol 2002;12:2651-8.
7. Best WR, Beckel JM, Singleton JW, et al. Development of a Crohn's disease activity index. National cooperative Crohn's disease study. Gastroenterology 1976; 70: 439-44
8. May A, Nachbar L, Ell C. Double-balloon enteroscopy (push-and-pull enteroscopy) of the small bowel: feasibility and diagnostic and therapeutic yield in patients with suspected small bowel disease. Gastrointastinal endoscopy 2005;62:62-70.
9. Gerson LB. Double-balloon enteroscopy: the new gold standard for small-bowel imaging? Editorial. Gastrointastinal endoscopy 2005;62:71-75.
10. Gölder SK, Schreyer AG, Endlicher E, Feuerbach S et al. Comparison of capsule endoscopy and magnetic resonance (MR) enteroclysis in suspected small bowel disease. International Journal of colorectal disease 2005; on line.
11. Hara AK, Leighton JA, Sharma VK, Heigh RI, Fleischer DE. Imaging of small bowel disease: comparison of capsule endoscopy, standard endoscopy, barium examination, and CT. Radiographics 2005;25:697-718.
12. Javier Sempere GA, Sanjuan VC, Chulia EM, et al. MRI evaluation of inflammatory activity in Crohn’s disease. AJR 2005; 84:1829-1835
13. Mylonaki M, Fritscher-Ravens A, Swain P. Wireless capsule endoscopy: a comparison with push enteroscopy in patients with gastroscopy and colonoscopy negative gastrointestinal bleeding.
14. MRI enteroclysis: Imaging technique of choice in diagnosis of small bowel diseases. B.M. Wiarda, E.J. Kuipers, A.P.J. Houdijk, H.A.R.E. Tuynman. Dig Dis Sci 2005;50:1036-40.
15. Pictorial essay: MR enteroclysis of inflammatory bowel diseases. B.M. Wiarda, E.J. Kuipers, M.A.Heitbrink, A. van Oijen, J.Stoker. AJR 2006; 187:522-531
|- Brief summary||Rationale:|
There has been no study so far that compared 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.
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.
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.
A total of 80 patients with suspected small bowel disease across 2 hospitals in the Netherlands will be included in this multicenter study; 40 patients with proven or suspected Crohn’s disease, and 40 patients with signs of chronic or repeated gastrointestinal bleeding with negative gastroscopy and colonoscopy
Main study parameters/endpoints:
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.
2. Patients with signs of chronic or repeated gastrointestinal bleeding with negative gastroscopy and colonoscopy.
Patients’ appreciation of the different diagnostic methods. This will be analysed by means of a questionnaire.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
MR enteroclysis: The dosis radiation received in order to place the nasogastric tube is very small (less than one X-ray of the Thorax).
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: The chance of complications as a result of the endoscopy is less than 1 per 1000 endoscopies
|- Main changes (audit trail)|
|- RECORD||5-sep-2006 - 21-mrt-2009|
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