Indigo Carmine Staining and Narrow Band Imaging (NBI) of Colonic Mucosa for Detection of Dysplasia in Ulcerative Colitis

Completed

Conditions studied: Ulcerative Colitis

In brief

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 be beneficial in the further assessment of abnormalities identified by these methods.

Key facts

Study ID

NCT00961948

Run by

Mayo Clinic

People needed

60

Starts

2009-06-01

Expected to finish

2013-02-01

Last updated by the study team

2013-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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