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Magnification Narrow Band Imaging Colonoscopy for Hereditary Non-Polyposis Colorectal Cancer Surveillance
This study has been completed.
First Received: April 10, 2006   Last Updated: November 15, 2007   History of Changes
Sponsored by: North West London Hospitals NHS Trust
Information provided by: North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00313755
  Purpose

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 Intervention
Colorectal Neoplasms, Hereditary Nonpolyposis
Procedure: Narrow Band Imaging

Genetics Home Reference related topics: Lynch syndrome
MedlinePlus related topics: Cancer Colonoscopy Colorectal Cancer Endoscopy
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment
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

Further study details as provided by North West London Hospitals NHS Trust:

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.

Estimated Enrollment: 60
Study Start Date: April 2006
Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313755

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

Additional Information:
No publications provided by North West London Hospitals NHS Trust

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 06/NBI5/15
Study First Received: April 10, 2006
Last Updated: November 15, 2007
ClinicalTrials.gov Identifier: NCT00313755     History of Changes
Health Authority: United Kingdom: National Health Service

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

Study placed in the following topic categories:
Digestive System Neoplasms
Metabolic Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Cancer, Hereditary Nonpolyposis, Type 1
Digestive System Diseases
Neoplastic Syndromes, Hereditary
Colorectal Neoplasms, Hereditary Nonpolyposis
Genetic Diseases, Inborn
Hereditary Nonpolyposis Colon Cancer
Gastrointestinal Neoplasms
Metabolic Disorder
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009