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Randomised Trial of NBI for Adenoma Detection

NCT ID: NCT00279357

Last Updated: 2007-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adenomas

Keywords

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NBI high risk group for adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Narrow Band Imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London North West Healthcare NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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Brian Saunders, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

London North West Healthcare NHS Trust

Locations

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North West London Hospitals NHS Trust - St Mark's

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Brian Saunders, MD FRCP

Role: CONTACT

Email: [email protected]

James East, MBChB MRCP

Role: CONTACT

Email: [email protected]

Facility Contacts

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Alan Warnes, PhD

Role: primary

Iva Hauptmannova, BSc MA

Role: backup

Other Identifiers

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05/NBI/121

Identifier Type: -

Identifier Source: org_study_id