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Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease (MA-51)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Capsule Endoscopy
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn's Disease focused on measuring capsule endoscopy, Crohn's disease, small bowel disease, inflammatory bowel disease, Patients with suspected small bowel Crohn's disease

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Arizona
  • Atlanta Gastroenterology
  • Stan Cohen
  • John Hopkins - Department of Medicine
  • UMass Memorial Medical Center
  • Minnesota Gastroenterology Associates
  • Private Practice
  • Thomas Jefferson University
  • McGill University Health Center
  • Rambam Medical Center
  • Malmo University Hospital UMAS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
June 14, 2007
Last Updated
September 30, 2020
Sponsor
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT00487396
Brief Title
Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
Acronym
MA-51
Official Title
Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
capsule endoscopy, Crohn's disease, small bowel disease, inflammatory bowel disease, Patients with suspected small bowel Crohn's disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Capsule Endoscopy
Intervention Description
Pillcam Platform with RAPID5 software and supporting SB2 capsules
Primary Outcome Measure Information:
Title
Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT)
Description
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.
Time Frame
four months from enrollment
Secondary Outcome Measure Information:
Title
Diagnostic Yield (CE vs. SBFT)
Description
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).
Time Frame
four months from enrollment
Title
Diagnostic Yield (CE vs. IC)
Description
McNemar test was preformed in order to evaluate the diagnostic yield of PillCam SB (CE) as compared to the diagnostic yield of ileocolonoscopy (IC).
Time Frame
four months from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Leighton, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Legnani, MD
Organizational Affiliation
Private Practice New York, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
10128
Country
United States
Facility Name
Atlanta Gastroenterology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Stan Cohen
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
John Hopkins - Department of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01612
Country
United States
Facility Name
Minnesota Gastroenterology Associates
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Private Practice
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Malmo University Hospital UMAS
City
Malmo
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24075891
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.
Results Reference
derived

Learn more about this trial

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

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