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Utilization of NBi in Assessing Luminal INflammaion in IBD (UNBLIND)

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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
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Procedure: NBI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NBI Procedure: NBI


Outcome Measures
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Primary Outcome Measures :
  1. Narrow band imaging (NBI) [ Time Frame: up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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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


Contacts
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Contact: Venkataraman Subramanian, MD, MRCP 01132068822 venkat.subramanian@leedsth.nhs.uk

Locations
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United Kingdom
Leeds Teaching Hospital NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Venkataraman Subramanian, MD, MRCP    01132068822    venkat.subramanian@leedsth.nhs.uk   
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
More Information
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Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02049775    
Other Study ID Numbers: UR13/10708
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases