NCT00908648

Brief Summary

Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

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

November 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

May 27, 2009

Completed
Last Updated

April 26, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

January 22, 2009

Results QC Date

January 22, 2009

Last Update Submit

March 30, 2021

Conditions

Keywords

screening colonoscopynarrow band imaging

Outcome Measures

Primary Outcomes (1)

  • Adenoma Detection

    Detection of adenoma, defined as the number of patients with \> 1 adenoma, under White Light or NBI visualization

    duration of colonoscopy procedure

Secondary Outcomes (1)

  • Detection of Flat and/or Depressed Adenomas

    duration of colonoscopy procedure

Study Arms (2)

1

NO INTERVENTION

standard white light

2

EXPERIMENTAL

Narrow Band Imaging

Procedure: Narrow Band Imaging

Interventions

Narrow Band Imaging

2

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year-old asymptomatic subjects at average-risk of CRC
  • positive FOBT participating in a national mass-screening program and referred for colonoscopy

You may not qualify if:

  • ongoing anticoagulation therapy
  • inadequate bowel cleansing
  • incomplete colonoscopy
  • refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Machida H, Sano Y, Hamamoto Y, Muto M, Kozu T, Tajiri H, Yoshida S. Narrow-band imaging in the diagnosis of colorectal mucosal lesions: a pilot study. Endoscopy. 2004 Dec;36(12):1094-8. doi: 10.1055/s-2004-826040.

    PMID: 15578301BACKGROUND
  • Chiu HM, Chang CY, Chen CC, Lee YC, Wu MS, Lin JT, Shun CT, Wang HP. A prospective comparative study of narrow-band imaging, chromoendoscopy, and conventional colonoscopy in the diagnosis of colorectal neoplasia. Gut. 2007 Mar;56(3):373-9. doi: 10.1136/gut.2006.099614. Epub 2006 Sep 27.

    PMID: 17005766BACKGROUND

MeSH Terms

Interventions

Narrow Band Imaging

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Results Point of Contact

Title
Dr Vittorio Terruzzi, Director of Gastroenterology Unit
Organization
Gastroenterology Unit, Valduce Hospital - Como - Italy

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 22, 2009

First Posted

May 27, 2009

Study Start

November 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 26, 2021

Results First Posted

May 27, 2009

Record last verified: 2021-03