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

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ClinicalTrials.gov Identifier: NCT00313755
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : November 16, 2007
Sponsor:
Information provided by:
London North West Healthcare NHS Trust

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).

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms, Hereditary Nonpolyposis Procedure: Narrow Band Imaging Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : April 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Number of patients with at least one adenoma
  2. after white light endoscopy compared with the number of patients
  3. with at least one adenoma after white light NBI in the right colon.

Secondary Outcome Measures :
  1. Total number of lesions detected with white light vs NBI.
  2. Number of advanced neoplasm detected with white light vs NBI.
  3. Number of hyperplastic polyps detected by white light vs NBI.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT00313755


Locations
United Kingdom
North West London Hospitals NHS Trust - St Mark's
London, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
London North West Healthcare NHS Trust
Investigators
Study Director: Brian Saunders, MD FRCP London North West Healthcare NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00313755     History of Changes
Other Study ID Numbers: 06/NBI5/15
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: November 2006

Keywords provided by London North West Healthcare NHS Trust:
colonoscopy, narrow band imaging,
high definition endoscopy
colorectal cancer
dysplasia
hereditary non-polyposis colorectal cancer
Lynch Syndrome
HNPCC

Additional relevant MeSH terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases