Ulcerative ColitisNCT00961948
Indigo Carmine Staining and Narrow Band Imaging (NBI) of Colonic Mucosa for Detection of Dysplasia in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Specific Aims:
Primary:
- 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 colonoscopy followed by NBI imaging. Secondary:
- To estimate the sensitivity and specificity of these modalities for dysplasia among UC patients who undergo surveillance colonoscopy.
- To assess intra- and inter-observer agreement for abnormalities identified by confocal laser microscopy among patients with chronic ulcerative colitis.
- To determine the specificity and sensitivity of confocal microscopy in the detection of dysplasia among patients with ulcerative colitis.
50 consecutive patients with clinically quiescent UC presenting for surveillance colonoscopy will be randomized to white light followed by NBI OR white light followed by indigo carmine staining. Identified abnormalities will then be targeted for confocal imaging in 40 patients. Immediately prior to confocal imaging, fluorescein 2.5 ml of 10% solution will be administered intravenously. For these patients, confocal images will also be obtained of the area around the lesion and of the colon segments as in the parent study and correlated with pathology. Gross activity will be determined by white light colonoscopy for each colon segment. At least 32 biopsies for surveillance will be obtained with additional biopsies of abnormalities present on white light, NBI or indigo carmine. Photographs will be obtained of all abnormalities prior to biopsy and of random mucosa without abnormalities. Intra- and inter-observer agreement will be based on the first 10 patients at each site through review of de-identified endoscopic photographs. If modifications are necessary because of poor agreement, re-assessment will be made after the next 10 patients. Otherwise each site will enroll 40 additional patients with agreement summarized and sensitivity and specificity of these techniques for detecting dysplasia
Significance: If intra and inter-observer agreement for mucosal abnormalities detected by indigo carmine and NBI modalities is shown to be good, in ulcerative colitis, then larger studies will be planned on UC surveillance populations. If confocal techniques are feasible then these will be integrated into larger studies.
- Conditions
- Ulcerative Colitis
- Keywords
- Indigo carmine dye spraying, Narrow band imaging (NBI), Confocal Microscopy
- Medical subject headings
- Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Michael F Picco, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961948
- Sponsor's protocol ID
- 09-000196
- Status last verified
- Feb 2013
- First submitted
- 18 Aug 2009
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00961948
- Acronym / sponsor ID
- 09-000196
- Conditions
- Ulcerative Colitis
- Keywords
- Indigo carmine dye spraying, Narrow band imaging (NBI), Confocal Microscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aims:
Primary:
- 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 colonoscopy followed by NBI imaging. Secondary:
- To estimate the sensitivity and specificity of these modalities for dysplasia among UC patients who undergo surveillance colonoscopy.
- To assess intra- and inter-observer agreement for abnormalities identified by confocal laser microscopy among patients with chronic ulcerative colitis.
- To determine the specificity and sensitivity of confocal microscopy in the detection of dysplasia among patients with ulcerative colitis.
50 consecutive patients with clinically quiescent UC presenting for surveillance colonoscopy will be randomized to white light followed by NBI OR white light followed by indigo carmine staining. Identified abnormalities will then be targeted for confocal imaging in 40 patients. Immediately prior to confocal imaging, fluorescein 2.5 ml of 10% solution will be administered intravenously. For these patients, confocal images will also be obtained of the area around the lesion and of the colon segments as in the parent study and correlated with pathology. Gross activity will be determined by white light colonoscopy for each colon segment. At least 32 biopsies for surveillance will be obtained with additional biopsies of abnormalities present on white light, NBI or indigo carmine. Photographs will be obtained of all abnormalities prior to biopsy and of random mucosa without abnormalities. Intra- and inter-observer agreement will be based on the first 10 patients at each site through review of de-identified endoscopic photographs. If modifications are necessary because of poor agreement, re-assessment will be made after the next 10 patients. Otherwise each site will enroll 40 additional patients with agreement summarized and sensitivity and specificity of these techniques for detecting dysplasia
Significance: If intra and inter-observer agreement for mucosal abnormalities detected by indigo carmine and NBI modalities is shown to be good, in ulcerative colitis, then larger studies will be planned on UC surveillance populations. If confocal techniques are feasible then these will be integrated into larger studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: two years
1 secondary outcome
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.
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F Picco, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.