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

NCT ID: NCT00487396

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-11-30

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Interventions

Capsule Endoscopy

Pillcam Platform with RAPID5 software and supporting SB2 capsules

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Leighton, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Peter Legnani, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice New York, New York

Locations

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Atlanta Gastroenterology

Atlanta, Georgia, United States

Stan Cohen

Atlanta, Georgia, United States

John Hopkins - Department of Medicine

Baltimore, Maryland, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Minnesota Gastroenterology Associates

Plymouth, Minnesota, United States

Private Practice

New York, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

McGill University Health Center

Montreal, Quebec, Canada

Rambam Medical Center

Haifa, , Israel

Malmo University Hospital UMAS

Malmo, , Sweden

Countries

United States; Canada; Israel; Sweden

References

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.

Reference Type: DERIVED

PMID: 24075891 (View on PubMed)

Other Identifiers

MA-51

Identifier Type: -

Identifier Source: org_study_id