Randomised Trial of NBI for Adenoma Detection
Randomised, Controlled Trial of Narrow Band Imaging (NBI) Versus Standard Endoscopy for Adenoma Detection
1 other identifier
interventional
214
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 17, 2006
CompletedFirst Posted
Study publicly available on registry
January 19, 2006
CompletedJune 29, 2007
June 1, 2007
January 17, 2006
June 28, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in number of patients with at least one histologically demonstrated adenoma between the two groups
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- patients over 18 years of age, patients in a high risk group for adenomas
You may not qualify if:
- patients with known colitis or polyposis, unable or unwilling to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North West London Hospitals NHS Trust - St Mark's
London, HA1 3UJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Saunders, MD FRCP
London North West Healthcare NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 17, 2006
First Posted
January 19, 2006
Study Start
January 1, 2006
Last Updated
June 29, 2007
Record last verified: 2007-06