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

Launched by MEDTRONIC - MITG · Feb 12, 2007

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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