Clinical Trials Directory

Trials / Completed

CompletedNCT00274209

Chromoendoscopy for Ulcerative Colitis Surveillance

Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Indiana University School of Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREChromoendoscopy with magnificationA 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.

Timeline

Start date
2005-12-01
Primary completion
2011-11-01
Completion
2011-11-01
First posted
2006-01-10
Last updated
2011-11-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00274209. Inclusion in this directory is not an endorsement.