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

This study has been completed.
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00434551
First received: February 11, 2007
Last updated: March 25, 2009
Last verified: February 2007
  Purpose

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.


Condition
Inflammatory Bowel Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Capsule Endoscopy in Patients With Suspected Small Bowel Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • • 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. [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • To assess the clinical impact made by CE in patients with clinically suspected small bowel Crohn's disease [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: February 2005
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with suspected Crohn's disease

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

clinics

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434551

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Repatriation General Hospital
Daw Park, South Australia, Australia, 5041
Australia, Victoria
Eastern Health
Box Hill, Victoria, Australia, 3128
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Cabrini Medical Centre
Malvern, Victoria, Australia, 3144
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Sir Charles Gardiner Hospital
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Warwick Selby, MD Royal Prince Alfred Hospital, Sydney, Australia
  More Information

No publications provided

Responsible Party: Corporate Director Clinical Affairs, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00434551     History of Changes
Other Study ID Numbers: MA-36
Study First Received: February 11, 2007
Last Updated: March 25, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Given Imaging Ltd.:
small bowel Crohn's disease
capsule endoscopy
PillCam SB
Patients with suspected small bowel Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014