Clinical trial NCT00487396: Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
Official title: Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: capsule endoscopy
Crohn's disease
small bowel disease
inflammatory bowel disease
Patients with suspected small bowel Crohn's disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2007-06-18
Enrollment: 98
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to validate the ability of Capsule Endoscopy (CE) to accurately diagnose small bowel (SB) Crohns disease in patients with symptoms of abdominal pain and diarrhea.

The primary objective of the study is to evaluate whether Capsule Endoscopy prior to colonoscopy will improve diagnosis in patients with suspected Crohns disease when compared to standard diagnostic testing.

Detailed description: Crohn's disease is a chronic, inflammatory disorder (IBD) affecting any part of the gastrointestinal tract but frequently involves the small and large bowel. Typical presenting symptoms include abdominal pain and diarrhea. Patients with this disorder may also have extraintestinal manifestations including arthritis, uveitis and aphthous stomatitis, erythema nodosum and pyoderma gangrenosum. The etiology of Crohn's disease is unknown. It affects populations around the globe and occurs at any age but it has a predilection to affect those between the ages of 15 and 35.

While about one half of patients have involvement of the ileum and large bowel, another third have disease isolated to the small bowel. Frequently, small bowel Crohn's disease can be difficult to diagnose using the traditional methods of evaluation including colonoscopy with ileoscopy and contrast radiography. Mucosal features of Crohn's disease are often subtle and difficult to identify by small bowel follow through (SBFT). The SBFT has traditionally been relied on to evaluate the small intestine for evidence of Crohn's disease but it has been shown to have a relatively low accuracy of only 30%. This has led to delays in the diagnosis of Crohn's disease with reports ranging from one to three years.

In the past few years, capsule endoscopy has sparked renewed interest in the investigation of IBD and Crohn's disease of the small bowel. A PillCam™ SB2 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 which in the past was inaccessible to physicians. A number of small pilot studies demonstrated capsule endoscopy efficacy in diagnosing SB Crohn's disease. 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 yield and clinical impact of Capsule Endoscopy (CE) in detecting suspected IBD and suspected Crohn's Disease of the small bowel when compared to SBFT.

Eligibility criteria: Inclusion Criteria:

* Patients ages 10-65 years, inclusive

  * Patient suffers from either

    * diarrhea for more than 6 weeks and less than 3 years and/or
    * abdominal pain for more than 6 weeks and less than 3 years and/or
    * extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis
  * Patient suffers from at least one of the symptoms / lab abnormalities listed below:

    * Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) within 3 months prior to enrollment
    * Unexplained anemia (less than normal limits) within 3 months prior to enrollment
    * Hypoalbuminemia (\<3.5 g/dl) within 3 months of enrollment
    * Positive ASCA within 3 months of enrollment
    * Abnormal white blood cell scan with in 3 months of enrollment
    * Stool negative for O\&P (C\&S) within 3 months of enrollment
    * Recurrent Fevers
    * Unexplained weight loss, failure to thrive in children
    * Gastro-intestinal bleeding including melena and/or hematochezia and/or FOBT positive.
    * Chronic perianal disease (fistula, fissure, peri-rectal abscess)
    * Abnormal small bowel SBFT and/or enteroclysis and/or abdominal CT not conclusively diagnostic for IBD
  * Patient is indicated for Ileo-Colonoscopy
  * Patient or legal guardian agrees to sign consent form

Exclusion criteria:

* Indeterminate Colitis where the purpose is only to make a definitive diagnosis and where the inclusion criteria are not otherwise met
* Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting.
* Definite long stricture seen on radiological exam.
* Suspected GI stricture, followed by agile™ study that could not prove patency of the GI tract.
* Known history of small bowel Crohn's Disease
* Current treatment for active IBD
* Positive Anti-tTG or anti-endomysial antibody
* Any of the following work-up within 1 year of study entry: Capsule Endoscopy, Colonoscopy and Upper GI/SBFT.
* Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
* Patient is pregnant

Primary outcomes:
measure: Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT)
timeFrame: four months from enrollment
Secondary outcomes:
measure: Diagnostic Yield (CE vs. SBFT)
timeFrame: four months from enrollment
measure: Diagnostic Yield (CE vs. IC)
timeFrame: four months from enrollment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Atlanta
country: United States
facility: Atlanta Gastroenterology
state: Georgia
city: Atlanta
country: United States
facility: Stan Cohen
state: Georgia
city: Baltimore
country: United States
facility: John Hopkins - Department of Medicine
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Plymouth
country: United States
facility: Minnesota Gastroenterology Associates
state: Minnesota
city: New York
country: United States
facility: Private Practice
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Malmo
country: Sweden
facility: Malmo University Hospital UMAS
Study officials:
affiliation: Mayo Clinic
name: Jonathan Leighton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice New York, New York
name: Peter Legnani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leighton JA, Gralnek IM, Cohen SA, Toth E, Cave DR, Wolf DC, Mullin GE, Ketover SR, Legnani PE, Seidman EG, Crowell MD, Bergwerk AJ, Peled R, Eliakim R. Capsule endoscopy is superior to small-bowel follow-through and equivalent to ileocolonoscopy in suspected Crohn's disease. Clin Gastroenterol Hepatol. 2014 Apr;12(4):609-15. doi: 10.1016/j.cgh.2013.09.028. Epub 2013 Sep 27.