Utilization of NBi in Assessing Luminal INflammaion in IBD (UNBLIND)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02049775|
Recruitment Status : Unknown
Verified February 2016 by The Leeds Teaching Hospitals NHS Trust.
Recruitment status was: Recruiting
First Posted : January 30, 2014
Last Update Posted : February 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis (UC)||Procedure: NBI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utility of Narrow Band Endoscopy in Predicting Short and Long Term Risk of Relapse in Patients With Quiescent Ulcerative Colitis|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||April 2015|
- Narrow band imaging (NBI) [ Time Frame: up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049775
|Contact: Venkataraman Subramanian, MD, MRCPfirstname.lastname@example.org|
|Leeds Teaching Hospital NHS Trust||Recruiting|
|Leeds, United Kingdom, LS9 7TF|
|Contact: Venkataraman Subramanian, MD, MRCP 01132068822 email@example.com|