NCT00633620

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

Enrollment Period

7 months

First QC Date

March 5, 2008

Last Update Submit

March 11, 2008

Conditions

Adenoma

Keywords

colonoscopynarrow band imagingadenomadiagnosiscolonoscopic adenoma detection

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate (number of polyps/number of patients examined)

    6 months

Secondary Outcomes (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

Study Arms (1)

colonoscopy

EXPERIMENTAL

Non-NBI HDTV colonoscopy

Device: Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)

Interventions

Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)DEVICE

colonoscopy withdrawal with NBI mode

Also known as: Olympus NBI colonoscope 180 HDTV
colonoscopy

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic persons \> 55 years willing to undergo screening colonoscopy

You may not qualify if:

  • Missing consent
  • Symptomatic persons
  • Poor general conditions, significant comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Hospitals, Campus Virchow Hospital

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (2)

  • 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.

    PMID: 22056301DERIVED

  • 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.

    PMID: 19014944DERIVED

MeSH Terms

Conditions

AdenomaDisease

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Thomas Rösch, Prof. Dr.

    Charité Medical University Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 12, 2008

Study Start

March 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

DE(1)