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CompletedNCT00908648Updated Apr 26, 2021Results posted

The Use of Narrow Band Imaging in Screening Colonoscopy

An interventional study of Narrow Band Imaging in Colonoscopy, sponsored by Valduce Hospital. Completed. Open to participants aged 50 Years to 69 Years. Per ClinicalTrials.gov, last updated 2021-04-26.

Sponsored by Valduce Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
50 Years to 69 Years
Sex
All
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Study 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.

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Conditions studied

  • Colonoscopy

Keywords

  • screening colonoscopy
  • narrow band imaging
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In context

Lead sponsor

Valduce Hospital is the lead sponsor of 29 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 50-69 year-old asymptomatic subjects at average-risk of CRC
  • positive FOBT participating in a national mass-screening program and referred for colonoscopy

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
206 participants (actual)

Study arms

  • No intervention
    1

    standard white light

  • Experimental
    2

    Narrow Band Imaging

    Procedure: Narrow Band Imaging

Interventions

  • ProcedureNarrow Band Imaging

    Narrow Band Imaging

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What researchers measure

Primary outcomes

  1. Adenoma Detection

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

    Time frame: duration of colonoscopy procedure

Secondary outcomes

  1. Detection of Flat and/or Depressed Adenomas

    number of patients with at least 1 flat and/or depressed adenoma

    Time frame: duration of colonoscopy procedure

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Results

Posted May 27, 2009

Participant flow

Gastroenterology Unit November 2007 - April 2008

Participant flow — Overall Study
MilestoneStandard White LightNarrow Band Imaging
Started108103
Completed108103
Not completed00

Outcome measures

PrimaryAdenoma Detection

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

Time frame:
duration of colonoscopy procedure
Reported as:
Number · participants
Adenoma Detection
participantsStandard White LightNarrow Band Imaging
Adenoma Detection6359
SecondaryDetection of Flat and/or Depressed Adenomas

number of patients with at least 1 flat and/or depressed adenoma

Time frame:
duration of colonoscopy procedure
Reported as:
Number · participants
Detection of Flat and/or Depressed Adenomas
participantsStandard White LightNarrow Band Imaging
Detection of Flat and/or Depressed Adenomas1022

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Standard White LightNarrow Band ImagingTotal
<=18 years000
Between 18 and 65 years9088178
>=65 years181533
Age, Continuous
Age, Continuous(years)Standard White LightNarrow Band ImagingTotal
Mean61.1 ± 5.859.6 ± 5.360.8 ± 5.4
Sex: Female, Male
Sex: Female, Male(Participants)Standard White LightNarrow Band ImagingTotal
Female474794
Male6156117
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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 15578301 ↗
  • 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. PubMed 17005766 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00908648
Lead sponsor
Valduce Hospital
Responsible party
Vittorio Terruzzi (MD, Valduce Hospital) — Principal investigator
First posted
May 27, 2009
Start date
Nov 2007
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
May 27, 2009
Last update
Apr 26, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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