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

NCT ID: NCT02049775

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30

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.

Conditions

Ulcerative Colitis (UC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NBI

Group Type: EXPERIMENTAL

NBI

Intervention Type: PROCEDURE

Interventions

NBI

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospital NHS Trust

Leeds, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Venkataraman Subramanian, MD, MRCP

Role: CONTACT

venkat.subramanian@leedsth.nhs.uk

01132068822

Facility Contacts

Venkataraman Subramanian, MD, MRCP

Role: primary

venkat.subramanian@leedsth.nhs.uk

01132068822

Other Identifiers

UR13/10708

Identifier Type: -

Identifier Source: org_study_id