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CompletedNCT03274115Updated Oct 2, 2019

BLI (Blue Light Imaging) for the Histological Characterization of Colorectal Polyps

An interventional study of BLI (Blue Laser Imaging) in Adenoma Colon, sponsored by Valduce Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-02.

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

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps using white light high-definition endoscopes is suboptimal. Blue laser imaging (BLI) is a new system for image-enhanced endoscopy using laser light, that is incorporated in the last generation Fuji high- definition videocolonscopes ELUXEO. Blue laser imaging (BLI) utilizes two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by excitation.This system should enhance the microvascular pattern of superficial lesions, making the histological prediction easier.

Aim of the study is to compare the accuracy of white light and BLI systems in real-time histology prediction of colonic polyps.

For this purpose all colonscopies will be performed in a standard fashion using white light. When a polyps \<10mm in size will be identified, patients will be randomized in two groups. In the Group 1 (White Light Grroup), all polyps \<10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made by means of white light. In the Group 2 (BLI Group) , all polyps \<10mm in size will be evaluated with BLI and scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE (Narrow-band Imaging International Colorectal Endoscopic) classification, indicating color/vessel/surface pattern. The level of endoscopist's confidence in predicting histology (high or low confidence) for any polyp will be also recorded.

Diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative predictive values) will be calculated comparing endoscopist's prediction and pathology report, considered as reference standard in both study groups in order to evaluate the accuracy of real-time histology prediction by using BLI or white light.

02

Conditions studied

  • Adenoma Colon

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All outpatients referred for colonoscopy

Exclusion criteria

Exclusion Criteria:

  • inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) \< 2 in one colonic segment)
  • previous colonic resection
  • inflammatory bowel disease
  • ereditary polyposic syndromes
  • patients on antithrombotics precluding polyp resection
  • absence of informed consent
  • inpatients or patients undergoing urgent colonscopy
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
600 participants (actual)

Study arms

  • No intervention
    White Light (WL)

    White light will be used for histology prediction of colonic polyps (hyperplastic versus adenomatous).

  • Active comparator
    Blue Light Imaging (BLI)

    Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps.

    Device: BLI (Blue Laser Imaging)

Interventions

  • DeviceBLI (Blue Laser Imaging)

    Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps

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What researchers measure

Primary outcomes

  1. Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology

    Diagnostic performances (sensitivity, specificity, positive and negative predictive values) in predicting colonic polyp histology will be calculated comparing endoscopist's prediction with pathology result (reference standard).

    Time frame: one year

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Study locations

1 site
  • Gastroenterology Unit, Valduce Hospital
    Como, 22100, Italy
07

References and documents

Publications

  • Rondonotti E, Paggi S, Amato A, Mogavero G, Andrealli A, Conforti FS, Conte D, Spinzi G, Radaelli F. Blue-light imaging compared with high-definition white light for real-time histology prediction of colorectal polyps less than 1 centimeter: a prospective randomized study. Gastrointest Endosc. 2019 Mar;89(3):554-564.e1. doi: 10.1016/j.gie.2018.09.027. Epub 2018 Sep 28. PubMed 30273590 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03274115
Lead sponsor
Valduce Hospital
Responsible party
Franco Radaelli (MD, Head of Gastrointestinal Endoscopy Unit, Valduce Hospital) — Principal investigator
First posted
Sep 6, 2017
Start date
Jul 1, 2017
Primary completion
Dec 1, 2017
Completion
Dec 30, 2017
Last update
Oct 2, 2019

Study contacts

Franco Radaelli
principal investigator · Valduce Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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