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

• 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 ]

• Change in patient management will be evaluated by the following parameters:
• • Patient level diagnosis of SB Crohn’s by each modality (i.e. CE, SBFT, ileo-colonoscopy) will be categorized as:
• 1. Small bowel disease present (will be categorized as mild, moderate or severe).
• 2. Suspicious for small bowel disease.
• 3. No small bowel disease present
• 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.

The aim of this study is to validate the ability of Capsule Endoscopy (CE) to accurately diagnose small bowel (SB) Crohns disease in patients with symptoms of abdominal pain and diarrhea.

The primary objective of the study is to evaluate whether Capsule Endoscopy prior to colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to standard diagnostic testing.

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)

Inclusion Criteria:

• Patients ages 10-65 years, inclusive

  • Patient suffers from either

    • diarrhea for more than 6 weeks and less than 3 years and/or
    • abdominal pain for more than 6 weeks and less than 3 years and/or
    • extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis

  • Patient suffers from at least one of the symptoms / lab abnormalities listed below:

    • Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) within 3 months prior to enrollment
    • Unexplained anemia (less than normal limits) within 3 months prior to enrollment
    • Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment
    • Positive ASCA within 3 months of enrollment
    • Abnormal white blood cell scan with in 3 months of enrollment
    • Stool negative for O&P (C&S) within 3 months of enrollment
    • Recurrent Fevers
    • Unexplained weight loss, failure to thrive in children
    • Gastro-intestinal bleeding including melena and/or hematochezia and/or FOBT positive.
    • Chronic perianal disease (fistula, fissure, peri-rectal abscess)
    • Abnormal small bowel SBFT and/or enteroclysis and/or abdominal CT not conclusively diagnostic for IBD
  • Patient is indicated for Ileo-Colonoscopy
  • Patient or legal guardian agrees to sign consent form

Exclusion criteria:

• Indeterminate Colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met
• Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting.
• Definite long stricture seen on radiological exam.
• Suspected GI stricture, followed by agile™ study that could not prove patency of the GI tract.
• Known history of small bowel Crohn's Disease
• Current treatment for active IBD
• Positive Anti-tTG or anti-endomysial antibody
• Any of the following work-up within 1 year of study entry: Capsule Endoscopy, Colonoscopy and Upper GI/SBFT.
• Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
• Patient is pregnant