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

Crohn's Disease Clinical Trial

— MA-51  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487396
• Other study ID #: MA-51
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: November 2010

Study information

• Verified date: September 2020
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Device:
• Capsule Endoscopy
Pillcam Platform with RAPID5 software and supporting SB2 capsules

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec
Israel	Rambam Medical Center	Haifa
Sweden	Malmo University Hospital UMAS	Malmo
United States	Atlanta Gastroenterology	Atlanta	Georgia
United States	Stan Cohen	Atlanta	Georgia
United States	John Hopkins - Department of Medicine	Baltimore	Maryland
United States	Private Practice	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Minnesota Gastroenterology Associates	Plymouth	Minnesota
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT)	To evaluate whether capsule endoscopy (CE) prior to ileocolonoscopy (IC) improves the diagnostic yield in patients with suspected Crohn's disease when compared to IC and SBFT. McNemar test was preformed in order to evaluate the diagnostic yield of IC combined with CE as compared to the diagnostic yield of IC combined with SBFT.	four months from enrollment
Secondary	Diagnostic Yield (CE vs. SBFT)	McNemar test was preformed in order to evaluate the diagnostic yield of PillCam SB (CE) as compared to the diagnostic yield of small bowel follow through (SBFT).	four months from enrollment
Secondary	Diagnostic Yield (CE vs. IC)	McNemar test was preformed in order to evaluate the diagnostic yield of PillCam SB (CE) as compared to the diagnostic yield of ileocolonoscopy (IC).	four months from enrollment