MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study
MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study
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.
Inclusion Criteria:

 -  Patient will be 10 years and older

 -  Patient suffers from abdominal pain and/or diarrhea for the last 6 weeks and/or
 expresses extra-intestinal manifestations of CD

 -  Patient has at least one of the following over the preceding 6 months (plus symptoms
 suspicious of small bowel Crohn's Disease):

 -  Positive inflammatory marker (ESR, CRP, thrombocytosis, leucocytosis, fecal
 lactoferrin, fecal α-1 antitrypsin)

 -  Unexplained anemia,

 -  Recurrent fever,

 -  Weight loss (at least 10% of normal body weight in adults),

 -  Hypoalbuminaemia (<3.5 g/dL),

 -  Gastro-intestinal bleeding,

 -  Chronic perianal disease (fistula, fissure),

 -  Abnormal white cell scan

 -  Positive ASCA

 -  First degree relative of a person suffering from IBD (only for subjects without
 known IBD),

 -  Patient underwent standard evaluation that includes colonoscopy and attempted
 ileoscopy and also SBFT within six months prior to enrollment, which were
 non-diagnostic. Blood tests should have been done within one month of enrolment.

 -  Patient or legal guardian agrees to sign the Informed Consent Form

 Exclusion Criteria:

 -  Patients with indeterminate colitis where the purpose is only to make a definitive
 diagnosis and where the inclusion criteria are not otherwise met

 -  Patient is known to suffer from intestinal obstruction (symptoms such as severe
 abdominal pain with accompanying nausea or vomiting)

 -  Definite stricture seen on SBFT

 -  Patient had suspected GI stricture, a Given® Patency capsule was administered and
 Patient did not pass the Patency capsule.

 -  Patient has a pacemaker or other implanted electro-medical device

 -  Patient has known history of small bowel Crohn's disease

 -  Patient on treatment for active IBD

 -  Patient with suspected celiac disease that has not been excluded

 -  Patient on non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or
 higher) during the 3 months preceding enrolment

 -  Patient is pregnant

 -  Patient has any condition, which precludes compliance with study and/or device
 instructions, such as swallowing problems

 -  Patient suffers from life threatening conditions

 -  Patient is currently participating in another clinical study that may directly or
 indirectly affect the results of this study