Indigo Carmine Staining and Narrow Band Imaging (NBI) of Colonic Mucosa for Detection of Dysplasia in Ulcerative Colitis
A Pilot Study for the Determination of Inter-observer Variation for Abnormalities Detected by Indigo Carmine Staining and Narrow Band Imaging Among Patients Undergoing Surveillance Colonoscopy for Ulcerative Colitis
1 other identifier
observational
60
1 country
1
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 be beneficial in the further assessment of abnormalities identified by these methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFebruary 27, 2013
February 1, 2013
3.7 years
August 18, 2009
February 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall estimates of inter- and intra-observer positive and negative agreement of at least 80% for the detection of abnormalities seen by white light colonoscopy followed by indigo carmine staining and white light colonoscopy followed by NBI imaging.
two years
Secondary Outcomes (1)
Confocal laser microscopy may be beneficial in the further assessment of abnormalities identified by these methods of white light colonoscopy followed by indigo carmine staining and white light colonoscopy followed by NBI imaging.
two years
Eligibility Criteria
Patients with clinically quiescent, histologically proven pan-ulcerative colitis for at least 8 years will be recruited from the outpatient gastroenterology clinic of the Mayo Clinic Florida and randomized to white light followed by NBI or white light followed by indigo carmine staining to include confocal microscopy.
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael F Picco, M.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
June 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 27, 2013
Record last verified: 2013-02