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

Inflammatory Bowel Diseases Clinical Trial

— MACCS  

Official title:

Evaluation of Capsule Endoscopy in Patients With Suspected Small Bowel Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434551
• Other study ID #: MA-36
• Status: Completed
• Start date: February 2005
• Est. completion date: February 2008

Study information

• Verified date: February 2007
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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 a-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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Australia	Eastern Health	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Repatriation General Hospital	Daw Park	South Australia
Australia	St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Cabrini Medical Centre	Malvern	Victoria
Australia	Sir Charles Gardiner Hospital	Nedlands	Western Australia
Australia	Royal Melbourne Hospital	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• To evaluate the yield of capsule endoscopy for the diagnosis of small bowel Crohn's disease in symptomatic patients with non-diagnostic standard work-up.		end of study
Secondary	• To assess the clinical impact made by CE in patients with clinically suspected small bowel Crohn's disease		end of study