Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274209
Status:
COMPLETED
Last Update Posted:
2011-11-22
First Post:
2006-01-06
Brief Title:
Chromoendoscopy for Ulcerative Colitis Surveillance
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None