Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy (BECOP-2)
Primary Purpose
Adenoma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma focused on measuring colonoscopy, narrow band imaging, adenoma, diagnosis, colonoscopic adenoma detection
Eligibility Criteria
Inclusion Criteria:
- Asymptomatic persons > 55 years willing to undergo screening colonoscopy
Exclusion Criteria:
- Missing consent
- Symptomatic persons
- Poor general conditions, significant comorbidity
Sites / Locations
- Charité University Hospitals, Campus Virchow Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
colonoscopy
Arm Description
Non-NBI HDTV colonoscopy
Outcomes
Primary Outcome Measures
adenoma detection rate (number of polyps/number of patients examined)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00633620
First Posted
March 5, 2008
Last Updated
March 11, 2008
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00633620
Brief Title
Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy
Acronym
BECOP-2
Official Title
Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy in a Private Practice Setting - A Large Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
colonoscopy, narrow band imaging, adenoma, diagnosis, colonoscopic adenoma detection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
colonoscopy
Arm Type
Experimental
Arm Description
Non-NBI HDTV colonoscopy
Intervention Type
Device
Intervention Name(s)
Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)
Other Intervention Name(s)
Olympus NBI colonoscope 180 HDTV
Intervention Description
colonoscopy withdrawal with NBI mode
Primary Outcome Measure Information:
Title
adenoma detection rate (number of polyps/number of patients examined)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Asymptomatic persons > 55 years willing to undergo screening colonoscopy
Exclusion Criteria:
Missing consent
Symptomatic persons
Poor general conditions, significant comorbidity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Rösch, Prof. Dr.
Organizational Affiliation
Charité Medical University Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University Hospitals, Campus Virchow Hospital
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22056301
Citation
Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
Results Reference
derived
PubMed Identifier
19014944
Citation
Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.
Results Reference
derived
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Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy
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