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Status unknownNCT02876133Updated Sep 26, 2018

Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection

An interventional study of narrow band imaging withdrawal and white light withdrawal in Colon Cancer and Colon Sessile Serrated Adenoma/Polyp, sponsored by Hospital Beatriz Ângelo. Status unknown at 3 sites in Portugal. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by Hospital Beatriz Ângelo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
987
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
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Study summary

Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.

Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.

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Conditions studied

  • Colon Cancer
  • Colon Sessile Serrated Adenoma/Polyp

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In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's planned enrollment of 987 is above the median of 250 across 412 interventional studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Hospital Beatriz Ângelo is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

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

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients scheduled for elective colonoscopies

Exclusion criteria

Exclusion Criteria:

  • known polyposis syndromes
  • primary sclerosing cholangitis
  • inflammatory bowel disease
  • personal colorectal cancer history
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
987 participants (estimated)

Study arms

  • Experimental
    Narrow band imaging withdrawal

    colonoscope withdrawal and mucosal inspection performed under narrow band imaging

    Device: narrow band imaging withdrawal

  • Placebo comparator
    white light withdrawal

    colonoscope withdrawal and mucosal inspection performed under white light imaging

    Device: white light withdrawal

Interventions

  • Devicenarrow band imaging withdrawal

    colonoscope withdrawal and mucosal inspection performed under narrow band imaging

  • Devicewhite light withdrawal

    colonoscope withdrawal and mucosal inspection performed under white light imaging

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What researchers measure

Primary outcomes

  1. average number of serrated lesions ≥10 mm detected per colonoscopy

    Time frame: immediate

Secondary outcomes

  1. Serrated class lesions detection rate

    number of patients with at least 1 lesion/total number of participants

    Time frame: immediate

  2. Serrated lesions <10 mm detected per colonoscopy

    Time frame: immediate

  3. SSL detection rate

    histologically defined according to the WHO criteria

    Time frame: immediate

  4. Adenoma detection rate

    number of patients with at least 1 adenoma/total number of participants

    Time frame: immediate

  5. Adenomas detected per colonoscopy

    Time frame: immediate

  6. Advanced (malignant) adenocarcinoma detection rate

    Time frame: immediate

  7. Incidence of procedure related adverse events

    Time frame: immediate

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Study locations

1 of 3 sites recruiting
  • Hospital Beatriz Ângelo
    Loures, Portugal
    Recruiting
  • Centro Hospitalar do Porto
    Porto, Portugal
    Not yet recruiting
  • Instituto Português de Oncologia do Porto
    Porto, Portugal
    Not yet recruiting
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References and documents

Publications

  • Rex DK, Ahnen DJ, Baron JA, Batts KP, Burke CA, Burt RW, Goldblum JR, Guillem JG, Kahi CJ, Kalady MF, O'Brien MJ, Odze RD, Ogino S, Parry S, Snover DC, Torlakovic EE, Wise PE, Young J, Church J. Serrated lesions of the colorectum: review and recommendations from an expert panel. Am J Gastroenterol. 2012 Sep;107(9):1315-29; quiz 1314, 1330. doi: 10.1038/ajg.2012.161. Epub 2012 Jun 19. PubMed 22710576 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2018, 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
NCT02876133
Lead sponsor
Hospital Beatriz Ângelo
Responsible party
Alexandre Ferreira (Gastroenterologist, Hospital Beatriz Ângelo) — Principal investigator
First posted
Aug 23, 2016
Start date
Nov 2016
Primary completion
Aug 2019 (estimated)
Completion
Aug 2019 (estimated)
Last update
Sep 26, 2018

Study contacts

Alexandre O Ferreira, MD
Contact
alex.gastrohep@gmail.com
Alexandre O Ferreira, MD
principal investigator · Hospital Beatriz Ângelo

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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