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Magnification Narrow Band Imaging Colonoscopy for Hereditary Non-Polyposis Colorectal Cancer Surveillance

Primary Purpose

Colorectal Neoplasms, Hereditary Nonpolyposis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Narrow Band Imaging
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms, Hereditary Nonpolyposis focused on measuring colonoscopy, narrow band imaging,, high definition endoscopy, colorectal cancer, dysplasia, hereditary non-polyposis colorectal cancer, Lynch Syndrome, HNPCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with HNPCC according to the Amsterdam II criteria patients over 18 years Exclusion Criteria: pregnant patients unable or unwilling to give consent

Sites / Locations

  • North West London Hospitals NHS Trust - St Mark's

Outcomes

Primary Outcome Measures

Number of patients with at least one adenoma
after white light endoscopy compared with the number of patients
with at least one adenoma after white light NBI in the right colon.

Secondary Outcome Measures

Total number of lesions detected with white light vs NBI.
Number of advanced neoplasm detected with white light vs NBI.
Number of hyperplastic polyps detected by white light vs NBI.

Full Information

First Posted
April 10, 2006
Last Updated
November 15, 2007
Sponsor
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00313755
Brief Title
Magnification Narrow Band Imaging Colonoscopy for Hereditary Non-Polyposis Colorectal Cancer Surveillance
Official Title
Back-to Back Trial of Narrow Band Imaging (NBI) With Magnification Versus Standard Colonoscopy for Colonic Neoplasia Surveillance in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
London North West Healthcare NHS Trust

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI)can help doctors detect more patients with at least one pre-cancerous area than conventional colonoscopy using white light alone in patients with genetically inherited high risk for bowel cancer (HNPCC).
Detailed Description
Colorectal cancer is the second commonest cause of cancer death. Some people have an inherited defect in the genes which repair DNA which results in a very high risk of colorectal (bowel) cancer at a young age. This syndrome is called hereditary non-polyposis colorectal cancer (HNPCC) or Lynch syndrome. Colonoscopic surveillance of HNPCC 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 HNPCC are difficult to see and may be advanced even if as small as a few millimeters. Endoscopists have used spraying dye on the lining of 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 two studies is not widely used in routine clinical practice in the UK. Narrow Band Imaging (NBI) is a technique that relies on light 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 surace pattern (pit pattern) of lesion which allows an 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 than 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, in particular NBI and autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non-cancerous areas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Hereditary Nonpolyposis
Keywords
colonoscopy, narrow band imaging,, high definition endoscopy, colorectal cancer, dysplasia, hereditary non-polyposis colorectal cancer, Lynch Syndrome, HNPCC

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Narrow Band Imaging
Primary Outcome Measure Information:
Title
Number of patients with at least one adenoma
Title
after white light endoscopy compared with the number of patients
Title
with at least one adenoma after white light NBI in the right colon.
Secondary Outcome Measure Information:
Title
Total number of lesions detected with white light vs NBI.
Title
Number of advanced neoplasm detected with white light vs NBI.
Title
Number of hyperplastic polyps detected by white light vs NBI.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with HNPCC according to the Amsterdam II criteria patients over 18 years Exclusion Criteria: pregnant patients unable or unwilling to give consent
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
Study Director
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
17682000
Citation
East JE, Suzuki N, Stavrinidis M, Guenther T, Thomas HJ, Saunders BP. Narrow band imaging for colonoscopic surveillance in hereditary non-polyposis colorectal cancer. Gut. 2008 Jan;57(1):65-70. doi: 10.1136/gut.2007.128926. Epub 2007 Aug 6.
Results Reference
derived

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Magnification Narrow Band Imaging Colonoscopy for Hereditary Non-Polyposis Colorectal Cancer Surveillance

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