Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy (BECOP-2)
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|ClinicalTrials.gov Identifier: NCT00633620|
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : March 12, 2008
Narrow Band Imaging (NBI) with high-definition (HDTV) visualization has been implemented into GI endoscopy with the purpose to better highlight endoluminal pathological structures by improving their contrast. Previous studies from referral centers could not show significant differences in terms of colonoscopic adenoma detection rate, but either very high adenoma rates or some numerical differences suggested that some benefit may exist which may become evident with average adenoma rates and/or large case numbers.
In a prospective randomized trial performed exclusively in a multicenter private practice setting involving 6 examiners with substantial life-time experience (>10.000 colonoscopies) 1200 patients will undergo HDTV screening colonoscopy with either NBI or conventional imaging technique on instrument withdrawal. Primary outcome measure is the adenoma detection rate (ADR; i.e. number of adenomas per patient).
|Condition or disease||Intervention/treatment||Phase|
|Adenoma||Device: Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)||Not Applicable|
in 5 private practices with 6 examiners, consecutive asymptomatic persons willing to undergo screening colonoscopy will be asked to participate in this randomized study.
After introduction of the colonoscope into the cecum, patients will be randomized into withdrawal with either the NBI mode or conventional imaging by using wide-angle colonoscopes with HDTV imaging (Olympus Corp., Hamburg, Germany) in both groups. Randomization lists will be used for group allocation in each individual practice. In the NBI group, switching back to conventional imaging, and the number of occasions for switching back and the reasons for it are documented in this group.
Patients bowel preparation consists mostly of polyethylene glycol lavage with 4-5 liters until clear rectal fluid is evacuated. All examiners shall take special care to wash and clean the entire large bowel during instrument introduction and withdrawal, in order to provide optimal imaging conditions.
The following parameters are documented:
- Age and sex of the patient
- Type and dosage of sedation
- Examination time, both for instrument introduction and withdrawal
- Polyp characteristics: size (measured by open forceps or snare), shape (pedunculated/elevated, sessile/flat, and location
- Polyp histology after removal using snare polypectomy or forceps removal (for polyps < 3 mm), or biopsy if there are contraindications
- Other lesions found such as cancers, diverticula, inflammatory lesions etc. The main outcome parameter is the adenoma detection rate (number of polyps/number of patients examined) in the two groups.
Secondary outcome measures include analysis of the total number of polyps, flat/sessile adenomas, small adenomas (< 1 cm), hyperplastic polyps with size determination and right-sided versus left-sided polyp location in both groups.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy in a Private Practice Setting - A Large Prospective Randomized Trial|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Non-NBI HDTV colonoscopy
Device: Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)
colonoscopy withdrawal with NBI mode
Other Name: Olympus NBI colonoscope 180 HDTV
- adenoma detection rate (number of polyps/number of patients examined) [ Time Frame: 6 months ]
- analysis of the total number of polyps, flat/sessile adenomas, small adenomas (< 1 cm), hyperplastic polyps with size determination and right-sided versus left-sided polyp location [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633620
|Charité University Hospitals, Campus Virchow Hospital|
|Berlin, Germany, 13353|
|Principal Investigator:||Thomas Rösch, Prof. Dr.||Charité Medical University Berlin|