Randomised Trial of NBI for Adenoma Detection

Adenomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00279357
• Other study ID #: 05/NBI/121
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2006
• Last updated: June 28, 2007
• Start date: January 2006

Study information

• Verified date: June 2007
• Source: London North West Healthcare NHS Trust
• Contact: Brian Saunders, MD FRCP
• Email: b.saunders[@]imperial.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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 of inter- and intra-observer variability.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Adenomas

Intervention

Procedure:
• Narrow Band Imaging

Locations

Country	Name	City	State
United Kingdom	North West London Hospitals NHS Trust - St Mark's	London

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in number of patients with at least one histologically demonstrated adenoma between the two groups
Secondary	Number of adenomas detected in each arm
Secondary	number of advance adenomas (>20% villous elements, >10mm, high grade dysplasia) detected in each arm
Secondary	Total number of flat adenomas detected in each arm
Secondary	total number of non-neoplastic lesion in each arm
Secondary	total number of patients with 3 or more adenomas detected in each arm
Secondary	total number of patients with 5 or more adenomas detected in each arm
Secondary	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
Secondary	Sub-group analysis of primary end point according to indication for colonoscopy