Magnification Narrow Band Imaging Colonoscopy for Hereditary Non-Polyposis Colorectal Cancer Surveillance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00313755|
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : November 16, 2007
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms, Hereditary Nonpolyposis||Procedure: Narrow Band Imaging||Not Applicable|
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|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
- 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.
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
|North West London Hospitals NHS Trust - St Mark's|
|London, Middlesex, United Kingdom, HA1 3UJ|
|Study Director:||Brian Saunders, MD FRCP||London North West Healthcare NHS Trust|