Randomised Trial of NBI for Adenoma Detection

June 28, 2007 updated by: London North West Healthcare NHS Trust

Randomised, Controlled Trial of Narrow Band Imaging (NBI) Versus Standard Endoscopy for Adenoma Detection

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference in number of patients with at least one histologically demonstrated adenoma between the two groups

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: Brian Saunders, MD FRCP, London North West Healthcare NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

June 29, 2007

Last Update Submitted That Met QC Criteria

June 28, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/NBI/121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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