Colonoscopy
Conditions
Keywords
screening colonoscopy, narrow band imaging
Brief summary
Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.
Interventions
PROCEDURENarrow Band Imaging
Narrow Band Imaging
Sponsors
Valduce Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* 50-69 year-old asymptomatic subjects at average-risk of CRC * positive FOBT participating in a national mass-screening program and referred for colonoscopy
Exclusion criteria
* ongoing anticoagulation therapy * inadequate bowel cleansing * incomplete colonoscopy * refusing to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection | duration of colonoscopy procedure | Detection of adenoma, defined as the number of patients with \> 1 adenoma, under White Light or NBI visualization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Flat and/or Depressed Adenomas | duration of colonoscopy procedure | number of patients with at least 1 flat and/or depressed adenoma |
Participant flow
Recruitment details
Gastroenterology Unit November 2007 - April 2008
Pre-assignment details
Patients undergoing incomplete procedure for inadequate bowel cleansing or failure to reach the cecum were excluded from randomization
Participants by arm
| Arm | Count |
|---|---|
| Standard White Light use of standard white light during the withdrawal phase of colonoscopy | 108 |
| Narrow Band Imaging use of narrow band imaging during the withdrawal phase of colonoscopy | 103 |
| Total | 211 |
Baseline characteristics
| Characteristic | Standard White Light | Narrow Band Imaging | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 15 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 88 Participants | 178 Participants |
| Age, Continuous | 61.1 years STANDARD_DEVIATION 5.8 | 59.6 years STANDARD_DEVIATION 5.3 | 60.8 years STANDARD_DEVIATION 5.4 |
| Sex: Female, Male Female | 47 Participants | 47 Participants | 94 Participants |
| Sex: Female, Male Male | 61 Participants | 56 Participants | 117 Participants |
Outcome results
Primary
Adenoma Detection
Detection of adenoma, defined as the number of patients with \> 1 adenoma, under White Light or NBI visualization
Time frame: duration of colonoscopy procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard White Light | Adenoma Detection | 63 participants |
| Narrow Band Imaging | Adenoma Detection | 59 participants |
Secondary
Detection of Flat and/or Depressed Adenomas
number of patients with at least 1 flat and/or depressed adenoma
Time frame: duration of colonoscopy procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard White Light | Detection of Flat and/or Depressed Adenomas | 10 participants |
| Narrow Band Imaging | Detection of Flat and/or Depressed Adenomas | 22 participants |