Chromoendoscopy for Ulcerative Colitis Surveillance

November 21, 2011 updated by: Michael Chiorean, Indiana University School of Medicine

Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ulcerative colitis satisfying criteria for surveillance colonoscopy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of dysplastic lesions by white light vs. chromoendoscopy
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Investigators

  • Principal Investigator: Michael V Chiorean, MD, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 6, 2006

First Submitted That Met QC Criteria

January 6, 2006

First Posted (Estimate)

January 10, 2006

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0509-71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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