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

NCT ID: NCT00434551

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-02-29

Brief Summary

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.

Detailed Description

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Patients with suspected Crohn's disease

No interventions assigned to this group

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

• 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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Given Imaging Ltd.

Principal Investigators

Warwick Selby, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Prince Alfred Hospital, Sydney, Australia

Locations

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Repatriation General Hospital

Daw Park, South Australia, Australia

Eastern Health

Box Hill, Victoria, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Cabrini Medical Centre

Malvern, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Sir Charles Gardiner Hospital

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

MA-36

Identifier Type: -

Identifier Source: org_study_id