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

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

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.

Study Overview

• Status: Completed
• Conditions: Adenoma Colon
• Intervention / Treatment: Device: BLI (Blue Laser Imaging)

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Como, Italy, 22100
    • Gastroenterology Unit, Valduce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All outpatients referred for colonoscopy

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	one year

Collaborators and Investigators

• Sponsor: Valduce Hospital
• Investigators: Principal Investigator: Franco Radaelli, Valduce Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 3, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 341/2017 bis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No