Randomised Trial of NBI for Adenoma Detection
Primary Purpose
Adenomas
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Narrow Band Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenomas focused on measuring NBI, high risk group for adenomas
Eligibility Criteria
Inclusion Criteria: patients over 18 years of age, patients in a high risk group for adenomas Exclusion Criteria: patients with known colitis or polyposis, unable or unwilling to give informed consent
Sites / Locations
- North West London Hospitals NHS Trust - St Mark'sRecruiting
Outcomes
Primary Outcome Measures
Difference in number of patients with at least one histologically demonstrated adenoma between the two groups
Secondary Outcome Measures
Number of adenomas detected in each arm
number of advance adenomas (>20% villous elements, >10mm, high grade dysplasia) detected in each arm
Total number of flat adenomas detected in each arm
total number of non-neoplastic lesion in each arm
total number of patients with 3 or more adenomas detected in each arm
total number of patients with 5 or more adenomas detected in each arm
assessment of video still for detection of neo-plastic or non-plastic nature of polyps, AFI, vs NBI vs NBI with magnification versus white light
Sub-group analysis of primary end point according to indication for colonoscopy
Full Information
NCT ID
NCT00279357
First Posted
January 17, 2006
Last Updated
June 28, 2007
Sponsor
London North West Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00279357
Brief Title
Randomised Trial of NBI for Adenoma Detection
Official Title
Randomised, Controlled Trial of Narrow Band Imaging (NBI) Versus Standard Endoscopy for Adenoma Detection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 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
4. Oversight
5. Study Description
Brief Summary
Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors detect more patients with at least one pre-cancerous polyp (adenoma) than conventional colonoscopy using white light alone?
May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro allow assessment of inter- and intra-observer variability.
Detailed Description
Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceded by a precancerous lesion called an adenoma (polyp). Detection and removal of adenomas at colonoscopy has been shown to reduce the death rate from colorectal cancer. However, despite meticulous examination there is a "miss rate" for adenomas at colonoscopy which ranges from 66-25% in back-to-back colonoscopy studies. The nature of the polyps which as well as being pedunculated (cherry like) can be flat or depressed making them difficult to see, which may contribute to the "miss rate".
The factors, which influence the endoscopist detection are not well studied. Polyp detection rates wary widely, even among experts. Techniques that highlight lesions have advanced in recent years. Chromoendoscopy, the current gold standard technique, relies on spraying dye on the bowel lining, has been shown to help pick up more pre-cancerous polyps in two of three studies; however it is not widely used as it is time consuming and requires extra equipment and training. Narrow band imaging (NBI) is a technique that relies in light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up adenomas 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. 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 is better than standard colonoscopy for detecting precancerous polyps. This is likely as it is similar to chromoendoscopy which is already shown to help. If a polyp is found we will use other types of endoscopy, particularly NBI with magnification and autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous polyps.
May 2007 protocol minor amendment: additional viewing by endoscopists outside St Mark's ro allow assessment of inter- and intra-observer variability. No additional data collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomas
Keywords
NBI, high risk group for adenomas
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Narrow Band Imaging
Primary Outcome Measure Information:
Title
Difference in number of patients with at least one histologically demonstrated adenoma between the two groups
Secondary Outcome Measure Information:
Title
Number of adenomas detected in each arm
Title
number of advance adenomas (>20% villous elements, >10mm, high grade dysplasia) detected in each arm
Title
Total number of flat adenomas detected in each arm
Title
total number of non-neoplastic lesion in each arm
Title
total number of patients with 3 or more adenomas detected in each arm
Title
total number of patients with 5 or more adenomas detected in each arm
Title
assessment of video still for detection of neo-plastic or non-plastic nature of polyps, AFI, vs NBI vs NBI with magnification versus white light
Title
Sub-group analysis of primary end point according to indication for colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients over 18 years of age, patients in a high risk group for adenomas
Exclusion Criteria:
patients with known colitis or polyposis, unable or unwilling to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Saunders, MD FRCP
Email
b.saunders@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
James East, MBChB MRCP
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
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Warnes, PhD
Email
alan.warnes@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Iva Hauptmannova, BSc MA
Email
iva.hauptmannova@nwlh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Brian Saunders, MD FRCP
12. IPD Sharing Statement
Learn more about this trial
Randomised Trial of NBI for Adenoma Detection
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