- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02049775
Utilization of NBi in Assessing Luminal INflammaion in IBD (UNBLIND)
Utility of Narrow Band Endoscopy in Predicting Short and Long Term Risk of Relapse in Patients With Quiescent Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory condition of unknown aetiology, characterized by a diffuse confluent mucosal inflammation of the colon starting from the rectum with a relapsing and remitting course. Conventional endoscopy was thought to be a reliable parameter of disease activity, but microscopic inflammation can persist despite normal mucosal findings. Histologically detectable inflammation is associated with a greater risk of subsequent relapse. A flare in UC activity is difficult to predict, but a simple, easily measured biological marker of relapse would be important in guiding the most appropriate therapy.
Recent technological advances in fiber optics, light sources, detectors, and molecular biology have stimulated development of numerous optical methods that promise to significantly improve our ability to evaluate human epithelium in vivo. These methods, collectively termed "optical biopsy," are nondestructive in situ assays of mucosal histopathology using light that can provide instantaneous tissue assessment. Narrow band imaging (NBI) is a novel technique that enhances the diagnostic capability of endoscopes in characterising tissues by using filters in a redgreenblue (RGB) sequential illumination system. This results in improved mucosal contrast and detail.
UC always involves the distal colon and activity is usually greatest in rectosigmoid area. This makes evaluation of the rectum and sigmoid an attractive marker in patients with UC. Unlike serum and faecal markers, endoscopic assessment of the mucosa is unlikely to be affected by systemic disease and would be acceptable test for patients and physicians.
We plan to evaluate THE rectosigmoid mucosa in patients with UC by flexible endoscope using both white light and NBI endoscopy. These patients will be followed by for one year or until they relapse, whichever comes first. The aim of our study is to develop endoscopic biomarkers to predict relapse in acute and quiescent UC.
Study Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leeds, United Kingdom, LS9 7TF
- Recruiting
- Leeds Teaching Hospital NHS Trust
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Contact:
- Venkataraman Subramanian, MD, MRCP
- Phone Number: 01132068822
- Email: venkat.subramanian@leedsth.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients referred for lower gastrointestinal endoscopy procedure will be recruited.
- Any age (1885 years), gender or ethnic background
- Able and willing to give an informed consent
Exclusion Criteria:
- Patients known to be intolerant to endoscopy.
- Patients with severe lifethreatening comorbidity as judged by the investigator.
- Patients on therapy with anticoagulation that may preclude taking any biopsies
- Pregnant women or breast feeding mothers
- Patient with toxic megacolon
- patients on medications known to cause bowel inflammation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: NBI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Narrow band imaging (NBI)
Time Frame: up to 2 years
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up to 2 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UR13/10708
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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