Utilization of NBi in Assessing Luminal INflammaion in IBD (UNBLIND)
Primary Purpose
Ulcerative Colitis (UC)
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
NBI
Sponsored by
About this trial
This is an interventional diagnostic trial for Ulcerative Colitis (UC)
Eligibility Criteria
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.
Sites / Locations
- Leeds Teaching Hospital NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NBI
Arm Description
Outcomes
Primary Outcome Measures
Narrow band imaging (NBI)
Secondary Outcome Measures
Full Information
NCT ID
NCT02049775
First Posted
January 20, 2014
Last Updated
February 18, 2016
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02049775
Brief Title
Utilization of NBi in Assessing Luminal INflammaion in IBD (UNBLIND)
Official Title
Utility of Narrow Band Endoscopy in Predicting Short and Long Term Risk of Relapse in Patients With Quiescent Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis (UC)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
8. Arms, Groups, and Interventions
Arm Title
NBI
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
NBI
Primary Outcome Measure Information:
Title
Narrow band imaging (NBI)
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Venkataraman Subramanian, MD, MRCP
Phone
01132068822
Email
venkat.subramanian@leedsth.nhs.uk
Facility Information:
Facility Name
Leeds Teaching Hospital NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Venkataraman Subramanian, MD, MRCP
Phone
01132068822
Email
venkat.subramanian@leedsth.nhs.uk
12. IPD Sharing Statement
Learn more about this trial
Utilization of NBi in Assessing Luminal INflammaion in IBD (UNBLIND)
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