An observational study in Ulcerative Colitis and Crohn's Disease, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-22.
Sponsored by Indiana University School of Medicine · Observational
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.
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 100 is close to the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with ulcerative colitis satisfying criteria for surveillance colonoscopy
Exclusion Criteria:
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.
Prevalence of dysplastic lesions by white light vs. chromoendoscopy
Time frame: 12 months
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Indiana University School of Medicine