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Chromoendoscopy for Ulcerative Colitis Surveillance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00274209
First Posted: January 10, 2006
Last Update Posted: November 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Chiorean, Indiana University
  Purpose
Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.

Condition Intervention
Ulcerative Colitis Crohn's Disease Procedure: Chromoendoscopy with magnification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Michael Chiorean, Indiana University:

Primary Outcome Measures:
  • Prevalence of dysplastic lesions by white light vs. chromoendoscopy [ Time Frame: 12 months ]

Biospecimen Retention:   Samples Without DNA
endoscopic biopsies

Enrollment: 100
Study Start Date: December 2005
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IBD patients at risk for neoplasia
Patients with long-standing ulcerative colitis or Crohn's colitis at risk for neoplasia.
Procedure: Chromoendoscopy with magnification
A blue dye (indigo carmine) will be sprayed prior to imaging the bowel lining using a zoom colonoscope. The dye is not absorbed and is safe for human use.

Detailed Description:

Patients with ulcerative colitis (UC) are at increased risk for colon cancer. Current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. Endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. Chromoendoscopy (CE) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether CE can replace standard colonoscopy in the surveillance of patients with UC is unknown.

Comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with UC who are candidates for surveillance colonoscopy. The yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ulcerative colitis satisfying criteria for surveillance colonoscopy
Criteria

Inclusion Criteria:

  • Ulcerative colitis, pancolitis > 8 years; left-sided > 15 years or
  • history of PSC or
  • history of previous dysplasia on colon biopsies or
  • family history of colon cancer in first degree relative

Exclusion Criteria:

  • any condition that precludes colonoscopy
  • expected survival less than 1 year
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274209


Locations
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Michael V Chiorean, MD Indiana University School of Medicine
  More Information

Responsible Party: Michael Chiorean, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT00274209     History of Changes
Other Study ID Numbers: 0509-71
First Submitted: January 6, 2006
First Posted: January 10, 2006
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Michael Chiorean, Indiana University:
Ulcerative colitis
Crohn's disease
Chromoendoscopy
Dysplasia
Neoplasia

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes