Inflammatory Bowel Diseases Clinical Trial
Official title:
Evaluation of Capsule Endoscopy in Patients With Suspected Small Bowel Crohn's Disease
This is a prospective study aimed to validate the ability of capsule endoscopy to accurately diagnose small bowel Crohn's disease in symptomatic patients who have a non-diagnostic standard workup. Patients will be randomized to undergo capsule endoscopy either one week or five weeks after enrolment. Patients will be followed up for up to 3 months after capsule endoscopy.
In the past few years, capsule endoscopy has sparked renewed interest in the investigation of
small bowel Crohn's disease. A PillCam™SB 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 such as Crohn's disease. It has been
demonstrated that capsule endoscopy identifies Crohn's disease when other methods are not
helpful. 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 accuracy and clinical impact of Capsule Endoscopy in
detecting suspected small Bowel Crohn's Disease whose initial evaluation was non-diagnostic.
It will also serve to better understand the impact of capsule endoscopy on the natural
history of the disorder.
Patients will be randomized to undergo capsule endoscopy either one week or five weeks after
enrolment. This will allow assessment of the natural history of this form of Crohn's disease
and ensure that any changes in CDAI and QOL after capsule endoscopy are not merely a result
of this natural history.
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