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Chromoendoscopy for Ulcerative Colitis Surveillance

NCT ID: NCT00274209

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ulcerative Colitis Crohn's Disease

Keywords

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Ulcerative colitis Crohn's disease Chromoendoscopy Dysplasia Neoplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IBD patients at risk for neoplasia

Patients with long-standing ulcerative colitis or Crohn's colitis at risk for neoplasia.

Chromoendoscopy with magnification

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Michael Chiorean

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael V Chiorean, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Indiana University Medical Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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0509-71

Identifier Type: -

Identifier Source: org_study_id