Clinical trial NCT00434551: MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study
Official title: Evaluation of Capsule Endoscopy in Patients With Suspected Small Bowel Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: small bowel Crohn's disease
capsule endoscopy
PillCam SB
Patients with suspected small bowel Crohn's disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 119
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: clinics

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.

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

Primary outcomes:
measure: • 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.
timeFrame: end of study
Secondary outcomes:
measure: • To assess the clinical impact made by CE in patients with clinically suspected small bowel Crohn's disease
timeFrame: end of study
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Daw Park
country: Australia
facility: Repatriation General Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Medical Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gardiner Hospital
state: Western Australia
Study officials:
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Warwick Selby, MD
role: PRINCIPAL_INVESTIGATOR
References: