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BECOP-2: Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT00633620
Collaborator
(none)
1,250
Enrollment
1
Location
1
Arm
7
Duration (Months)
177.8
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy in a Private Practice Setting - A Large Prospective Randomized Trial
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: colonoscopy

Non-NBI HDTV colonoscopy

Device: Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)
colonoscopy withdrawal with NBI mode
Other Names:
  • Olympus NBI colonoscope 180 HDTV

    		•

    Outcome Measures

    Primary Outcome Measures

    1. adenoma detection rate (number of polyps/number of patients examined) [6 months]

    Secondary Outcome Measures

    1. 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 [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Asymptomatic persons > 55 years willing to undergo screening colonoscopy
    Exclusion Criteria:

    • Missing consent

    • Symptomatic persons

    • Poor general conditions, significant comorbidity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité University Hospitals, Campus Virchow Hospital Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Principal Investigator: Thomas Rösch, Prof. Dr., Charité Medical University Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00633620
    Other Study ID Numbers:
    • Charite-CVK-Endo-1
    • Berlin Colonoscopy Project 2
    First Posted:
    Mar 12, 2008
    Last Update Posted:
    Mar 12, 2008
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    colonoscopy
    narrow band imaging
    adenoma
    diagnosis
    colonoscopic adenoma detection
    Additional relevant MeSH terms:
    Adenoma

    Study Results

    No Results Posted as of Mar 12, 2008