NCT03274115

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

Completed NA Last updated 2 October 2019

What this trial tests

NA trial testing BLI (Blue Laser Imaging) in Adenoma Colon in 600 participants. Completed in 30 December 2017.

Timeline

1 July 2017

Primary endpoint
1 December 2017

30 December 2017

Quick facts

Lead sponsor	Valduce Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	600
Start date	1 July 2017
Primary completion	1 December 2017
Estimated completion	30 December 2017
Sites	1 location across Italy

Drugs / interventions tested

• BLI (Blue Laser Imaging)

Conditions studied

• Adenoma Colon — all drugs for Adenoma Colon →

Sponsor

Valduce Hospital

Who can join

Adults 18 to 80, any sex, with Adenoma Colon. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Rondonotti E, Paggi S, Amato A, Mogavero G, et al · · 2019 · cited 16× · PMID 30273590 · DOI 10.1016/j.gie.2018.09.027