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AdenomasNCT00279357

Randomised Trial of NBI for Adenoma Detection

A study testing Narrow Band Imaging in people with Adenomas, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenomas
What is being tested?
Narrow Band Imaging
Type of treatment
Surgery or procedure
How many people
214 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2006to not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients over 18 years of age, patients in a high risk group for adenomas

Who cannot join

  • patients with known colitis or polyposis, unable or unwilling to give informed consent

Trial locations and contacts

1 site in 1 country.

Brian Saunders, MD FRCP contact

b.saunders@imperial.ac.uk

James East, MBChB MRCP contact

jameseast@yahoo.com

United Kingdom1 site, 1 recruiting
  • North West London Hospitals NHS Trust - St Mark's

    London, HA1 3UJ

    Alan Warnes, PhD, alan.warnes@nwlh.nhs.uk

    Iva Hauptmannova, BSc MA, iva.hauptmannova@nwlh.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Adenomas
Being tested
Narrow Band Imaging
Keywords
NBI, high risk group for adenomas
Medical subject headings
Adenoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narrow Band ImagingProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)
  1. Number of adenomas detected in each arm

  2. number of advance adenomas (>20% villous elements, >10mm, high grade dysplasia) detected in each arm

  3. Total number of flat adenomas detected in each arm

  4. total number of non-neoplastic lesion in each arm

  5. total number of patients with 3 or more adenomas detected in each arm

  6. total number of patients with 5 or more adenomas detected in each arm

  7. 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

  8. Sub-group analysis of primary end point according to indication for colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2006 (estimated)
  2. Study startJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
214 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279357
Sponsor's protocol ID
05/NBI/121
Status last verified
Jun 2007
First submitted
17 Jan 2006
Last updated
29 Jun 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Narrow Band Imaging in people with Adenomas, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Brian Saunders, MD FRCP (b.saunders@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in number of patients with at least one histologically demonstrated adenoma between the two groups. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2007.

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