Chromoendoscopy for Ulcerative Colitis Surveillance
|ClinicalTrials.gov Identifier: NCT00274209|
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : November 22, 2011
|Condition or disease||Intervention/treatment|
|Ulcerative Colitis Crohn's Disease||Procedure: Chromoendoscopy with magnification|
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.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis|
|Study Start Date :||December 2005|
|Primary Completion Date :||November 2011|
|Study Completion Date :||November 2011|
IBD patients at risk for neoplasia
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 ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274209
|United States, Indiana|
|Indiana University Medical Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Michael V Chiorean, MD||Indiana University School of Medicine|