NBI With Magnification for Dysplasia Detection in Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Narrow Band Imaging
colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring colonoscopy, narrow band imaging (NBI), ulcerative colitis
Eligibility Criteria
Inclusion Criteria: petients with colitis who meet surveillance criteria patients over 18 years of age Exclusion Criteria: pregnant patients unable or unwilling to give informed consent patients with severe active colitis who would be unsafe to endoscope
Sites / Locations
- North West London Hospitals NHS Trust - St Mark'sRecruiting
- Nottingham Univesrity Hospitals NHS Trust, Queen's Medical CentreRecruiting
Outcomes
Primary Outcome Measures
Effectiveness of NBI versus Light endoscopy
Secondary Outcome Measures
Are more precancerous lessions found in total with NBI?
Are more advanced precancerous lesions found with NBI?
Are more patients found with more that one precancerous lesion with NBI?
How Many lessions are successfully completely removed via the endoscope?
Full Information
NCT ID
NCT00292175
First Posted
February 14, 2006
Last Updated
September 21, 2007
Sponsor
London North West Healthcare NHS Trust
Collaborators
Nottingham University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00292175
Brief Title
NBI With Magnification for Dysplasia Detection in Ulcerative Colitis
Official Title
Randomised,Controlled Trial of Narrow Band Imaging With Magnification (NBI) Versus White Light Endoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
London North West Healthcare NHS Trust
Collaborators
Nottingham University Hospitals NHS Trust
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI) helps doctors detect more patients with at leat one pre-cancerous area (dysplasia associated lession or mass, MALMs) than conventional colonoscopy using white light alone.
Detailed Description
Colorectal cancer is the second commonest cause of cancer death. Patients with colitis have a substantially increased risk of death from colorectal cancer which increases with lenght of time the patient has had colitis. This can be as high as a 30% chance of colorectal cancer after 30 years of colitis. Colonoscopic surveillance of colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed.
Precancerous lesions in colitis are difficult to see and endoscopist have used spraying dye on the lining of the bowel (chromoendoscopy) successfully to improve detection of abnormal areas: however this is time consuming and requires extra time and equipment and despite the benefits seen in multiple studies is not widely used in routine clinical practice in the UK.
Narrow band imaging (NBI) is a technique that relies on light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network. It is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. With magnification it allows assessment of the fine mucosal surface pattern (pit pattern) of lesion which allows and assessment of their likelihood of being precancerous. Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon.
We aim to see if NBI with magnification is better that standard colonoscopy for detecting precancerous areas. This is likely as it produces images similar to chromoendoscopy which is already shown to help. If a potentially precancerous area is found we will use other types of endoscopy, particularly NBI autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous areas
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
colonoscopy, narrow band imaging (NBI), ulcerative colitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Narrow Band Imaging
Intervention Type
Procedure
Intervention Name(s)
colonoscopy
Primary Outcome Measure Information:
Title
Effectiveness of NBI versus Light endoscopy
Secondary Outcome Measure Information:
Title
Are more precancerous lessions found in total with NBI?
Title
Are more advanced precancerous lesions found with NBI?
Title
Are more patients found with more that one precancerous lesion with NBI?
Title
How Many lessions are successfully completely removed via the endoscope?
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
petients with colitis who meet surveillance criteria
patients over 18 years of age
Exclusion Criteria:
pregnant patients
unable or unwilling to give informed consent
patients with severe active colitis who would be unsafe to endoscope
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Saunders, MD, FRCP
Phone
0044208235
Ext
4227
Email
b.saunders@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
James East, BSc, MBChB, MRCP
Phone
0044208235
Ext
4025
Email
jameseast@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Saunders, MD, FRCP
Organizational Affiliation
London North West Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
North West London Hospitals NHS Trust - St Mark's
City
London
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Warnes, PhD
Phone
0044208 869
Ext
2011
Email
alan.warnes@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Iva Hauptmannova, BSc MA
Phone
0044208 869
Ext
5286
Email
iva.hauptmannova@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Brian Saunders, MD FRCP
Facility Name
Nottingham Univesrity Hospitals NHS Trust, Queen's Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krish Ragunath, Dr
First Name & Middle Initial & Last Name & Degree
Krish Ragunath, Dr
12. IPD Sharing Statement
Learn more about this trial
NBI With Magnification for Dysplasia Detection in Ulcerative Colitis
We'll reach out to this number within 24 hrs