Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Crohn's disease is a chronic, inflammatory disorder (IBD) affecting any part of the
      gastrointestinal tract but frequently involves the small and large bowel. Typical presenting
      symptoms include abdominal pain and diarrhea. Patients with this disorder may also have
      extraintestinal manifestations including arthritis, uveitis and aphthous stomatitis, erythema
      nodosum and pyoderma gangrenosum. 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.

      While about one half of patients have involvement of the ileum and large bowel, another third
      have disease isolated to the small bowel. Frequently, small bowel Crohn's disease can be
      difficult to diagnose using the traditional methods of evaluation including colonoscopy with
      ileoscopy and contrast radiography. 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%. This has led to delays in the diagnosis
      of Crohn's disease with reports ranging from one to three years.

      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. 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.

      This study is designed to determine the yield and clinical impact of Capsule Endoscopy (CE)
      in detecting suspected IBD and suspected Crohn's Disease of the small bowel when compared to
      SBFT.
    

Intervention name(s): Capsule Endoscopy
Intervention type(s): Device
Intervention description(s): Pillcam Platform with RAPID5 software and supporting SB2 capsules
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: capsule endoscopy; Crohn's disease; small bowel disease; inflammatory bowel disease; Patients with suspected small bowel Crohn's disease