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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00633620
First received: March 5, 2008
Last updated: March 11, 2008
Last verified: March 2008

March 5, 2008
March 11, 2008
March 2007
October 2007   (final data collection date for primary outcome measure)
adenoma detection rate (number of polyps/number of patients examined) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00633620 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy
Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy in a Private Practice Setting - A Large Prospective Randomized Trial

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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Adenoma
Device: Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)
colonoscopy withdrawal with NBI mode
Other Name: Olympus NBI colonoscope 180 HDTV
Experimental: colonoscopy
Non-NBI HDTV colonoscopy
Intervention: Device: Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1250
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Asymptomatic persons > 55 years willing to undergo screening colonoscopy

Exclusion Criteria:

  • Missing consent
  • Symptomatic persons
  • Poor general conditions, significant comorbidity
Both
55 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00633620
Charite-CVK-Endo-1, Berlin Colonoscopy Project 2
No
Prof. Thomas Rösch, M.D., Central Interdisciplinary Endoscopy Unit, Charité Berlin, CVK
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Thomas Rösch, Prof. Dr. Charité Medical University Berlin
Charite University, Berlin, Germany
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP