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

NCT03274115 | Completed

• 1 other identifier: 341/2017 bis
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenoma Colon

Outcome Measures

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).

  one year

Study Arms (2)

White Light (WL)

NO INTERVENTION

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

Blue Light Imaging (BLI)

ACTIVE COMPARATOR

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

Device: BLI (Blue Laser Imaging)

Interventions

BLI (Blue Laser Imaging) DEVICE

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

Blue Light Imaging (BLI)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All outpatients referred for colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Valduce Hospital: lead

Study Sites (1)

Gastroenterology Unit, Valduce Hospital

Como, 22100, Italy

Location

Related Publications (1)

• 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.

  PMID: 30273590 DERIVED

Study Officials

• Franco Radaelli

  Valduce Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head of Gastrointestinal Endoscopy Unit

Model Details: Patients with at least one polyp \<1 cm in size will be randomized in two groups. In the Group 1 (White Light Group), all polyps \<10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made. 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. The level of endoscopist's confidence in predicting real-time histology (high or low confidence) for any polyp will be also recorded.

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 6, 2017
• Study Start: July 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 30, 2017
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)