The COMRADE study.

Completed

• Conditions: 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.

• Registration Number: NL-OMON23200
• Lead Sponsor: Schering AG, Christiane Pering, M.D.Siemens Nederland, Ronald Prinsze

Brief Summary

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.<br> 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.<br> 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.<br> 4. Umschaden HW, Gasser J. MR enteroclysis. Radiol Clin North Am 2003;41:231-48.<br> 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.<br> 6. Gourtsoyiannis N, Papanikolaou N, Grammatikakis J, Prassopoulos P. MR enteroclysis: technical considerations and clinical applications. Eur Radiol 2002;12:2651-8.<br> 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<br> 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.<br> 9. Gerson LB. Double-balloon enteroscopy: the new gold standard for small-bowel imaging? Editorial. Gastrointastinal endoscopy 2005;62:71-75.<br> 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. <br> 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.<br> 12. Javier Sempere GA, Sanjuan VC, Chulia EM, et al. MRI evaluation of inflammatory activity in Crohn’s disease. AJR 2005; 84:1829-1835<br> 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.<br> 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.<br> 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<br>

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Patients of >18 and < 75 years

2. One of the following patient groups:

Exclusion Criteria

1. Patients with suspected intra-abdominal abscess

2. Abdominal surgery in the 6 weeks prior to inclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.