Chromoendoscopy for Ulcerative Colitis Surveillance

Ulcerative Colitis Clinical Trial

Official title:

Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274209
• Other study ID #: 0509-71
• Status: Completed
• Phase: N/A
• First received: January 6, 2006
• Last updated: November 21, 2011
• Start date: December 2005
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University Medical Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of dysplastic lesions by white light vs. chromoendoscopy		12 months	No