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Chromoendoscopy for Ulcerative Colitis Surveillance

Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00274209
Enrollment
100
Registered
2006-01-10
Start date
2005-12-31
Completion date
2011-11-30
Last updated
2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Ulcerative colitis, Crohn's disease, Chromoendoscopy, Dysplasia, Neoplasia

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.

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.

Interventions

PROCEDUREChromoendoscopy 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.

Sponsors

Indiana University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence of dysplastic lesions by white light vs. chromoendoscopy12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026