Status:
COMPLETED
Indigo Carmine Staining and Narrow Band Imaging (NBI) of Colonic Mucosa for Detection of Dysplasia in Ulcerative Colitis
Lead Sponsor:
Mayo Clinic
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
A prospective, randomized trial to determine indigo carmine dye spraying and narrow band imaging (NBI) of colonic mucosa to detect dysplasia in ulcerative colitis (UC). Confocal laser microscopy may b...
Detailed Description
Specific Aims: Primary: 1. To assess intra- and inter-observer agreement for the detection of abnormalities seen by white light colonoscopy followed by indigo carmine staining and white light colono...
Eligibility Criteria
Inclusion
- Clinically quiescent (UC) disease will be defined as a colitis activity index \<8 at the time of enrollment.
- Scheduled for routine, clinically-indicated colonoscopy surveillance
Exclusion
- Patients unable to give informed consent,
- Pregnant or female patients of child bearing age who are sexually active an not practicing birth control methods. (in this group a pregnancy test is required as per routine clinical care)
- Poor colonic preparation (\<90% colon visualization)
- Documented allergy to indigo carmine
- Coagulopathy that can not be corrected (INR\> 1.5 and/or platelet count\<50,000)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00961948
Start Date
June 1 2009
End Date
February 1 2013
Last Update
February 27 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224