Chromoendoscopy for Ulcerative Colitis Surveillance

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. Identifier: NCT00274209
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):
Michael Chiorean, Indiana University

Brief Summary:
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 or disease Intervention/treatment
Ulcerative Colitis Crohn's Disease Procedure: Chromoendoscopy with magnification

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.

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis
Study Start Date : December 2005
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

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

Biospecimen Retention:   Samples Without DNA
endoscopic biopsies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 identifier (NCT number): NCT00274209

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

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

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

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