Randomised Trial of NBI for Adenoma Detection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by North West London Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00279357
First received: January 17, 2006
Last updated: June 28, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention
Adenomas
Procedure: Narrow Band Imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomised, Controlled Trial of Narrow Band Imaging (NBI) Versus Standard Endoscopy for Adenoma Detection

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

Primary Outcome Measures:
  • Difference in number of patients with at least one histologically demonstrated adenoma between the two groups

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 214
Study Start Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279357

Contacts
Contact: Brian Saunders, MD FRCP b.saunders@imperial.ac.uk
Contact: James East, MBChB MRCP jameseast@yahoo.com

Locations
United Kingdom
North West London Hospitals NHS Trust - St Mark's Recruiting
London, United Kingdom, HA1 3UJ
Contact: Alan Warnes, PhD       alan.warnes@nwlh.nhs.uk   
Contact: Iva Hauptmannova, BSc MA       iva.hauptmannova@nwlh.nhs.uk   
Principal Investigator: Brian Saunders, MD FRCP         
Sponsors and Collaborators
North West London Hospitals NHS Trust
Investigators
Principal Investigator: Brian Saunders, MD FRCP North West London Hospitals NHS Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00279357     History of Changes
Other Study ID Numbers: 05/NBI/121
Study First Received: January 17, 2006
Last Updated: June 28, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by North West London Hospitals NHS Trust:
NBI
high risk group for adenomas

Additional relevant MeSH terms:
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 21, 2014