Multicenter Randomized Controlled Comparison of Two Different Video Capsule Endoscopy Systems to Diagnose Small Bowel Bleeding and/or Inflammation (DUOCAPS)

Introduction: The development of video capsule endoscopy (VCE) has been a significant advance for the non-invasive evaluation of the small bowel. The first videocapsule endoscope, (PillCam SB - Given Imaging, Yoqne'am, Israel) became commercially available in 2001. Since then its role in the diagnostic arsenal of gastrointestinal endoscopy has steadily increased. Two years ago a new device, the Endocapsule (Olympus Medical Systems, Tokyo, Japan), was introduced. This system uses different technology and produces higher resolution images. Aims: Primary aim of this study was to compare the diagnostic yield of the Pillcam SB and the Endocapsule. Secondary aim was to prospectively determine whether a second procedure increases the diagnostic yield of VCE in the evaluation of small bowel pathology. Methods: In this multicentre study six European centers cooperated. Inclusion criteria were occult or overt gastrointestinal bleeding without a cause found at gastroscopy or colonoscopy, suspicion of Crohn disease or suspicion of an exacerbation in patients with known Crohn disease. Excluded were patients with a suspected stricture in the GI-tract. Patients were randomized for the order in which the capsules were swallowed. There was a 1 to 2 week interval between the two VCE studies. The first examination was reviewed by the local expert and used for clinical practice. The second examination was reviewed by one of the expert reviewers from another centre. Both reviewers were made aware of the indication (bleeding or Crohn disaese) but blinded to the rest of the clinical history and the results of the other procedure. Results: Between April 2006 and May 2008, 110 patients have been included. We have so far collected the baseline data of 107 patients. The indication for VCE was gastrointestinal bleeding in 86 patients (80%), suspected Crohn disease in 20 patients and suspected flare of Crohn disease in 1 patient. The blinded review of the second procedure is currently being performed and we expect these data to be available in March 2009. Conclusion: This study has shown that it is feasible for patients to undergo two VCE's with a 1 to 2 week interval. Most (80%) VCE's in this study were performed for suspected small bowel bleeding. The comparison between the two types of VCE's will be made after the blinded review of all registrations has been completed (03/2009).