Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease (MA-51)

• The Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related [ Time Frame: four months from enrollment ] [ Designated as safety issue: No ]
  The number of positive findings related to Crohn that were detected by capsule endoscopy procedure and ileo-colonoscopy as compared to the number of findings related to Crohn that were detected by ileo-colonoscopy and small bowel follow through(SBFT) procedures.
  
  

• Small Bowel Disease Present (Will be Categorized as Mild, Moderate or Severe)or Suspicious for Small Bowel Disease or No Small Bowel Disease Present. [ Time Frame: four months from enrollment ] [ Designated as safety issue: No ]
  
• The Additional Diagnostic Value and Sensitivity of CE Compared With Ileo-colonoscopy and SBFT Will be Evaluated by the Number of Positive Findings, Detected by Each Modality, Which Were Considered by the Investigator to be Crohn's Disease Related. [ Time Frame: four months from enrollment ] [ Designated as safety issue: No ]
  

Device: Capsule Endoscopy
Pillcam Platform with RAPID5 software and supporting SB2 capsules

Crohn's disease is a chronic, inflammatory disorder(IBD) affecting any part of the gastrointestinal tract but frequently involves the small and large bowel. (1,2,3) Typical presenting symptoms include abdominal pain and diarrhea. (1,2,3) Patients with this disorder may also have extraintestinal manifestations including arthritis, uveitis and aphthous stomatitis, erythema nodosum and pyoderma gangrenosum.(1,2) The etiology of Crohn's disease is unknown. It affects populations around the globe and occurs at any age but it has a predilection to affect those between the ages of 15 and 35. (1,2,3,4) While about one half of patients have involvement of the ileum and large bowel, another third have disease isolated to the small bowel. (1,2) Frequently, small bowel Crohn's disease can be difficult to diagnose using the traditional methods of evaluation including colonoscopy with ileoscopy and contrast radiography.(1,2) Mucosal features of Crohn's disease are often subtle and difficult to identify by small bowel follow through (SBFT). The SBFT has traditionally been relied on to evaluate the small intestine for evidence of Crohn's disease but it has been shown to have a relatively low accuracy of only 30%. (5,6,7,8,9,) This has led to delays in the diagnosis of Crohn's disease with reports ranging from one to three years.(7,8,9) In the past few years, capsule endoscopy has sparked renewed interest in the investigation of IBD and Crohn's disease of the small bowel. A PillCam™ SB2 capsule (Given Imaging Ltd, Yoqneam, Israel) is an ingestible, disposable video camera that transmits high quality images of the small intestinal mucosa. This enables the small intestine to be readily accessible to physicians investigating for the presence of small bowel disorders which in the past was inaccessible to physicians.(7,9,10,11,12) A number of small pilot studies demonstrated capsule endoscopy efficacy in diagnosing SB Crohn's disease. Diagnostic yields of 70% have been reported in small series of studies performed in suspected small bowel Crohn's disease.( 9,10,11,12) This study is designed to determine the yield and clinical impact of Capsule Endoscopy in detecting suspected IBD and suspected Crohn's Disease of the small bowel when compared to SBFT. (6,7,8,9,10)